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• CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device’s infusion sets (FDA Recall Number: Z-1442-2020).Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

  CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market. The following is a summary of each individual product recall details:

  CMEAmerica BodyGuard® Infusion Pump Recall Details

  On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall.

  CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard® infusion pump may continue to be used in certain situations in accordance with the Operator’s Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.

  To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic:

  • Use of products in the field in accordance with the Operator’s Manual and the additional mitigations outlined in the updated customer letter;
  • Product service and repair activities at CME America and Authorized Service Depots; and
  • Supply of infusion sets and accessories to support the infusion pumps remaining in the field.

  The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient’s body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient’s vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

  The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.

  • BodyGuard 121
  • BodyGuard 323
  • BodyGuard 545*
  • BodyGuard 575*
  • BodyGuard 545 ColorVision
  • BodyGuard 575 ColorVision
  • CMExpress

  *Note: These two pump models were inadvertently left out of the initial customer notification

  CMEAmerica BodyGuard® Microset Infusion Set Recall Details

  On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers.

  To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company’s September recall announcement to customers.

  Affected products include:

  • CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.

  Customer inquiries related to either recall, as well as adverse reaction/events experienced with the product should be addressed to CME America Support Center at 877-263-0111.

• GSK Consumer Healthcare is voluntarily recalling five lots (listed below) of Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due to the potential for green plastic pieces or shavings from bottle caps to be present in the product. There is a potential risk of choking or physical injury to the soft tissues of the mouth or gastrointestinal tract of a consumer using the product who may not see a broken piece or shaving of plastic cap.These lots were distributed from October 28, 2019 through January 21, 2020 within the United States to retail stores and online retailers nationwide. The recall is limited to the five lots listed below:

  Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872 Lot: MP8B (EXP Sep2021)	Benefiber Prebiotic Fiber Supplement, 500G UPC 886790218302 Lots: YT2Y (EXP Oct2021) 7D6E (EXP Nov2021)	Benefiber Prebiotic Fiber Supplement, 760G UPC 8886790211907 Lots: UV5C (EXP Oct2021) 648H (EXP Nov2021)
  See image below	See image below	See image below

  As of the date of the recall announcement, GSK Consumer Healthcare has received one consumer complaint of a green particle observed inside a bottle of product.

  Patient safety and product quality are our utmost priorities at GSK Consumer Healthcare.

  GSK Consumer Healthcare is taking all appropriate steps to notify its retail and wholesale customers impacted by this recall and is arranging for return of all recalled products.

  Consumers that have Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder in their possession are advised to check the lot information on the product to see if it is part of the five lots being recalled. If the consumer finds that they have a recalled product, they should stop use immediately.

  For information on the recall, to request a refund on recalled products, to report an adverse experience or for any other inquiries regarding Benefiber, consumers can call the GSK Contact Center at 1-800-452-0051, Monday – Friday, 8:00am – 6:00pm EST.

  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

  This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
• SUGAR LAND, Texas, April 23, 2020 — QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi. Fresenius Kabi recalled multiple lots of Ketorolac on April 20, 2020 due to the presence of particulate matter found in the reserve sample vials.QuVa has reached out to all hospital pharmacy customers who purchased product from the lots affected and has asked them to: quarantine anything that is in stock to prevent use in direct patient care; complete a return response form to capture the amount of unused product; and return the finished goods to QuVa for destruction.Listed below are the recalled lots distributed directly to hospital pharmacies between February 13, 2020 and April 21, 2020.

  Product Description	Product Code	Lot Numbers
  R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50ml in Sodium Chloride—60ml BD syringe	70092-1433-50	30009563, 30009539, 30009489, 30009412, 30009413, 30009411, 30009410, 30009388, 30009387, 30009228, 30009227, 30009139, 30009138, 30009074, 30009073, 30008949, 30008859, 30008861, 30008554, 30008198, 30008721

  Customers with questions about the recall can email QuVa at QuVaRecallApril2020@Quvapharma.com or contact QuVa Pharma Customer Service at 888.339.0874

• Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:

  NDC No.	Description	Lot	Expiration Date
  60846-301-15	Nizatidine Oral Solution	06598004A	04/2020
  60846-301-15	Nizatidine Oral Solution	06599001A	12/2020
  60846-301-15	Nizatidine Oral Solution	06599002A	12/2020

  The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA.

  Amnealis notifying its direct customers by mailing (FED Ex Standard Overnight) a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

  Customers who purchased the impacted product directly from Amneal can call Inmar at (855) 319-4807, Monday – Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com for further information. Consumers should contact their physician or other healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

  Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

  Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.

  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

  Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

•  FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease.  We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA).  These medicines have a number of side effects, including serious heart rhythm problems that can be life-threatening.We have reviewed case reports in the FDA Adverse Event Reporting System database, the published medical literature, and the American Association of Poison Control Centers National Poison Data System concerning serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT prolonging medicines.  These adverse events included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases, death.  We are continuing to investigate these safety risks in patients with COVID-19 and will communicate publicly when more information is available.BACKGROUND: Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria.  Hydroxychloroquine is also FDA-approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.Hydroxychloroquine and chloroquine:
  • should be used for COVID-19 only when patients can be appropriately monitored in the hospital as required by the EUA or are enrolled in a clinical trial with appropriate screening and monitoring. FDA is reviewing the safety of their use when used outside of the setting of hospitalized patients for whom use was authorized.
  • have not been shown to be safe and effective for treating or preventing COVID-19.
  • are being studied in clinical trials for COVID-19, and FDA authorized their temporary use during the COVID-19 pandemic under limited circumstances through the EUA, and not through regular FDA approval.
  • being used under the EUA when supplied from the Strategic National Stockpile, the national repository of critical medical supplies to be used during public health emergencies.
  • can cause abnormal heart rhythms such as QT interval prolongation
  • can cause dangerously rapid heart rate called ventricular tachycardia.
  • pose risks that may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition.
  • should be used with caution in Patients who also have other health issues such as heart and kidney disease, who are likely to be at increased risk of these heart problems when receiving these medicines.

  RECOMMENDATION:

  • Patients taking hydroxychloroquine or chloroquine for FDA-approved indications to treat malaria or autoimmune conditions should continue taking their medicine as prescribed.
  • The benefits of these medicines outweigh the risks at the recommended doses for these conditions.

  Do not stop taking your medicine without first talking to your health care professional and talk to them if you have any questions or concerns 

  Be aware that there are no proven treatments for COVID-19 and no vaccine.  If you are receiving hydroxychloroquine or chloroquine for COVID-19 and experience irregular heartbeats, dizziness, or fainting, seek medical attention right away by calling 911.

• Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials.Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the shortterm (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine injection should not exceed 5 days.Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019, as well as a copy of the label:

  Product Name/Product size	NDC Number	Product Code	Batch Number	Expiration Date	First Ship Date	Last Ship Date
  Ketorolac Tromethamine Injection, USP, 30 mg / mL, 1 mL fill in a 2 mL amber vial	63323-162-01	160201	6118737	04/2020	05/30/2018	06/27/2018
  			6118902	04/2020	08/01/2018	08/15/2018
  			6119052	05/2020	06/25/2018	07/25/2018
  			6119752	08/2020	09/28/2018	12/06/2018
  			6122349	07/2021	09/16/2019	11/04/2019
  			6122538	09/2021	11/01/2019	12/16/2019
  Ketorolac Tromethamine Injection, USP, 60 mg / 2 mL (30 mg / mL), 2 mL fill in a 2 mL amber vial	63323-162-02	160202	6119229	06/2020	08/09/2018	10/30/2018
  			6119273	06/2020	09/26/2018	03/30/2019
  			6119843	09/2020	11/11/2019	01/07/2020
  			6121115	02/2021	03/30/2019	04/22/2019
  			6121451	03/2021	04/29/2019	08/05/2019
  			6121452	03/2021	07/12/2019	10/22/2019
  			6121496	03/2021	06/21/2019	12/10/2019

  Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius-kabi.com/us/pharmaceutical-product-updatesExternal Link Disclaimer.

  Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

  Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging.The company has determined that one (1) isolated TRUE METRIX AIR Blood Glucose Meter was packaged into a TRUE METRIX Blood Glucose Meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. If a consumer does not notice the incorrect unit of measure, it is possible that the meter glucose result will be read as a lower blood glucose result than expected, and this may result in the patient’s glucose level remaining high, which can lead to serious injury or impairment with risk of death.There is one (1) affected TRUE METRIX AIR meter with serial number TA1548753 that was packaged into a TRUE METRIX Blood Glucose Meter Kit with the Lot number KW0135 and with UDI # (01)00021292006075(17)200831(10)KW0135(21)TA1548753. It has been determined that this kit was distributed nationwide in the United States in February 2019. Trividia Health has not received any reports of patient injury or an adverse event related to this voluntary recall.Consumers who have or may have the TRUE METRIX AIR meter should do the following:
  • Check to confirm if you have the affected TRUE METRIX AIR meter by obtaining the meter serial number (TA1548753) from the serial number label located on the back of the meter, and then visit www.TrividiaHealth.com/air-product-noticeExternal Link Disclaimer or call Trividia Health toll-free at 1-800-518-5726, Monday-Friday, 8AM-8PM EST.
  • If you have the affected TRUE METRIX AIR meter, please stop using the meter and call Trividia Health immediately to verify the serial number, and to expedite return and replacement of the affected TRUE METRIX AIR meter at no charge.
  • Consumers may continue to test blood glucose using any other Trividia Health blood glucose meter not included in this voluntary recall while waiting for their replacement meter to arrive. Use only the test strips that are intended for use with your blood glucose meter.

  Notifications will be sent to US pharmacies, durable medical equipment providers and distributors who may have received this device from Trividia’s customer.

  Patient safety is a top priority at Trividia Health. The company has notified the U.S. Food and Drug Administration (FDA) of this voluntary product recall and is working with the customer who received the affected meter to quickly resolve this matter.

  Users within the USA may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online or by phone.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
• Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.

  Product	NDC Number	Lot No	Expiry Date
  Tetracycline HCl Capsules 250 mg 100 count	23155-017-01	H190666	JUL 2022
  Tetracycline HCl Capsules 500 mg 100 count	23155-018-01	G190609	JUN 2022
  Tetracycline HCl Capsules 500 mg 100 count	23155-018-01	G190610	JUN 2022
  Tetracycline HCl Capsules 500 mg 100 count	23155-018-01	G190611	JUN 2022
  Tetracycline HCl Capsules 500 mg 100 count	23155-018-01	L191027	NOV 2022
  Tetracycline HCl Capsules 500 mg 100 count	23155-018-01	L191028	NOV 2022
  Tetracycline HCl Capsules 500 mg 100 count	23155-018-01	K190953	OCT 2022
  Tetracycline HCl Capsules 500 mg 100 count	23155-018-01	K190952	OCT 2022

  These drug products are manufactured by Avet Pharmaceuticals Labs Inc. and distributed under the Heritage Pharmaceuticals Inc. label. The voluntary recall is being initiated due to low out of specification dissolution test results.

  Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event.

  Tetracycline HCl Capsules USP, 250 mg and 500 mg are indicated in the treatment of infections caused by susceptible strains of the designated organisms, including upper and lower respiratory infections, skin and soft tissues infections, infections caused by Rickettsiae, as adjunctive therapy in severe acne. The recalled Tetracycline HCl Capsules 250 mg and 500 mg lots were distributed to wholesalers and distributors Nationwide in United States between August 2019 and March 2020.

  Avet is notifying its distributors and customers by a separate notification to distributors and through Qualanex and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product. Pharmacies and healthcare facilities that have the drug product subject to this recall should immediately stop dispensing this drug product.

  Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341. Monday – Friday, 8:00 am – 5:00 pm, EST and or recall@qualanex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

  Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening. Patients should not stop taking clopidogrel without talking to their prescribing physician. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman. Simvastatin occasionally causes myopathy which is a disease of the muscles. Finally, allergic reactions are also possible and could also be life threatening. International Laboratories, LLC also reports that to date, no complaints have been received related to this event detailing medical illnesses or harmful effects.Clopidogrel Tablets USP 75 mg are a platelet inhibitor (blood thinner) indicated for the use in patient with acute coronary syndrome, recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke.The product was distributed nationwide and delivered to the distribution centers in Arkansas, Georgia, Indiana, California and Maryland, and distributed to retail stores in all US States.International Laboratories, LLC is notifying distributors and customers by letter and is arranging for return of all recalled products. Consumers who have purchased this product should stop using and return the product to the location of purchase for a full refund. For questions regarding return of product please call Inmar at 855-258-7280 or via email internationallabs@inmar.com or by using mailing address Recall Coordinator 635 Vine St. Winston Salem, NC 27101 Inmar’s business hours are (Monday – Friday 9 AM – 5 PM EST).Consumers should also contact their physician or healthcare provider if they are experiencing any health concerns that may be related to taking or using this drug product.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
• Conagra Brands, Inc., a Russellville, Ark. establishment, is recalling approximately 130,763 pounds of not ready-to-eat chicken bowl products because the product may contain extraneous material, specifically small rocks, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
  The frozen, not-ready-to-eat chicken bowl items were produced on Jan. 23, 2020. The following products are subject to recall: [View Labels (PDF Only)]
  9.5-oz. cartons containing “Healthy Choice POWER BOWLS Chicken Feta & Farro” with lot code 5006002320, UPC code 072655001800 and a best by date of 10/19/2020 on the label.
  9.5-oz. cartons containing “Healthy Choice POWER BOWLS Chicken Feta & Farro, BOILS ÈNERGIE Poulet feta et épeautre” with lot code 5006002320, UPC code 072655003026 and a best by date of 10/19/2020 on the label.
  The products subject to recall bear establishment number “P115” printed on the packaging next to the lot code. These items were shipped to retail locations nationwide and exported to Canada.
  The problem was discovered when the firm received consumer complaints about rocks being in the products and the firm then notified FSIS of the issue.
  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
  FSIS is concerned that some product may be in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away.
  FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at http://www.fsis.usda.gov/recalls.
  Consumers with questions about the recall or seeking a refund can contact Conagra Brands Consumer Care at 1-800-672-8240 or at Consumer.Care@conagra.com. Member of the media with questions about the recall can contact Daniel Hare, Conagra Brands Senior Director of Communication, at (312) 549-5355.
• Recalled Product
  LeMaitre Over the Wire Embolectomy Catheter
  Catalog Numbers and Lot Numbers: See full list
  Manufacturing Dates : May 5, 2014 to July 17, 2019
  Distribution Dates: November 7, 2014 to March 5, 2020
  Devices Recalled in the U.S.: 49,393
  Date Initiated by Firm: March 10, 2020   Who May be Affected

Health care providers using the LeMaitre Over the Wire Embolectomy Catheter
Patients undergoing embolectomy or thrombectomy procedures with the use of these catheters
What to Do
On March 17, 2020, LeMaitre Vascular, Inc. sent customers an Urgent Medical Device Recall letter advising them of the product issue and provided the following instructions:
Check your inventory and immediately quarantine any recalled devices.
Complete the form at the end of the letter. Please note that you must return the form even if you have no devices in inventory.
Scan the reply form and send it to recalls@lemaitre.com.
Be aware, if you have recalled devices at your facility, LeMaitre Vascular, Inc. will send you instructions for returning the devices. Once the recalled devices have been received by LeMaitre Vascular, they will arrange for replacement material.
If you have transferred devices to another facility, please forward a copy of the recall letter to them.
Contact Information
Customers with questions may contact Rose Lerer by email at rlerer@lemaitre.com or by phone at 781-425-1671, Monday through Friday from 8:00 AM to 4:30 PM Eastern Time.
Additional Resources:
Medical Device Recall Database Entry

• The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.
  This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen (a substance that could cause cancer). FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
  BACKGROUND: Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
  RECOMMENDATION:
  Consumers: The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.
  Patients: Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
  Consumers and Patients: In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the FDA’s recommended steps which include ways to safely dispose of these medications at home.
  Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
  Complete and submit the report online
  Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form or submit by fax to 1-800-FDA-0178
• Guan’s Mushroom Co of Commerce, CA is recalling all cases of its 200g/7.05 ounce packages of Enoki Mushroom (Product of Korea) because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
  The recalled products were distributed from CA, NY, PA in retail stores through produce distributors or wholesalers.
  The Enoki comes in a 200g/7.05ounces, clear plastic package with the description “Enoki Mushroom” in English, Korean and French, and Guan’s logo in the front. At the back, there are UPC code: 859267007013 and package code 14-1 at lower right corner.
  The product is being shipped in a white cardboard box with 25 pcs of 200g. The box contains Guan’s logo in green color and #02473.
  No illnesses have been reported to date in connection with this problem.
  The potential for contamination was noted after routine testing by State of California revealed the presence of Listeria monocytogenes in 200g package of Enoki.
  The distribution of the product has been suspended. Consumers who have purchased 200g packages of Enoki are urged to return them to the place of purchase for a full refund. Consumers with question may contact the company at 323.223.1188.
• Mountain Rose Herbs (MRH) of Eugene, Oregon is recalling all sizes of its Organic Kudzu Root Herbal Supplement from Lot #24247-X and #24247 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
  The product comes in a clear plastic or poly-woven bag, net weight ranges from 4 oz. to 50 lbs., marked with lot #24247-X
  External Link Disclaimer
  and #24247
  External Link Disclaimer
  . The lot number is located on the principal display panel on the lower left of the label (see linked label examples).
  The recalled Organic Kudzu Root Herbal Supplement was distributed to customers who ordered from mountainroseherbs.com, purchased at the company’s retail shop in Eugene, Oregon, or placed mail orders by phone or fax between the dates of 6/17/2019 to 3/2/2020. It is possible MRH customers also resold the Kudzu Root to their own clientele.
  Mountain Rose Herbs also distributed product directly to customers in AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, British of Columbia, Nova Scotia, Ontario, and Quebec of Canada.
  No illnesses have been reported to date. We are initiating this recall as a precautionary measure. The potential for contamination was noted after testing by the company revealed the presence of Salmonella in a portion of its ingredients in inventory. Production of the product has been suspended while we continue our investigation.
  We conduct this recall with the knowledge of the U.S. Food and Drug Administration.
  Consumers who have purchased the affected Kudzu Root are urged not to consume and should return product to the place of purchase for a full refund. Consumers with questions may contact Mountain Rose Herbs at 1-800-879-3337 X.109, Mon-Fri, 8 am-4:30 pm PT, or at claims@mountainroseherbs.com.
• March 13th, 2020, WinCo Foods, LLC. of Boise, ID is recalling frozen Blackberries in a 16 oz. bag and frozen Berry Medley in 16 oz. and 32 oz. bags, manufactured by Rader Farms of Lynden, WA, because both products have the potential to be contaminated with Norovirus. Norovirus is a highly contagious virus. Typical symptoms of norovirus infection are acute onset of vomiting, watery, non-bloody diarrhea with abdominal cramps, and nausea. Systemic manifestations include, fever, myalgia and malaise, anorexia, and headache. Although most symptoms end within 48 hours, the elderly, young children and immunocompromised persons may develop prolonged or more severe symptoms.
  WinCo Foods has removed the recalled products from store shelves.
  Product was distributed to WinCo Foods stores in Arizona, California, Idaho, Montana, Nevada, Oklahoma, Oregon, Washington, Texas, and Utah.
  THIS NOTICE AFFECTS THE FOLLOWING PRODUCTS (see attached labels). The Best By Code is located on the front of the package near the product image.
  WINCO FOODS FROZEN BLACKBERRIES, 16 OZ. BAG – UPC: 70552-30502, Best By Code Dec/09/2021.
  WINCO FOODS FROZEN BERRY MEDLEY, 16 OZ. BAG – UPC: 70552-30522, Best By Code Dec/09/2021.
  WINCO FOODS FROZEN BERRY MEDLEY, 32 OZ. BAG – UPC: 70552-30512, Best By Code Dec/09/2021.
  No customer illnesses have been reported to date. WinCo Foods was informed by the FDA that a sample of the product was tested by the FDA and found to be contaminated with Norovirus.
  Consumers who have purchased the products are urged to destroy or return them to the stores for a full refund of the product.
  Consumers with questions may contact the company at (1-800-824-1706) (Business hours: Mon-Fri 7:30-4:30 MST).
• AFC Distribution Corp. (“AFC”) of Rancho Dominguez, California is voluntary recalling Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02, utilized in various prepared menu offerings with sell-by dates ranging from 02/19/2020 to 03/13/2020, because this ingredient may have a potential to be contaminated with Vibrio parahaemolyticus. Vibrio parahaemolyticus is an organism which can cause illnesses such as nausea, vomiting, diarrhea, fever and chills.
  The recalled ingredient, Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), was distributed to designated retail AFC sushi counters, where it is further processed into prepared sushi items, within grocery stores, cafeterias, and corporate dining centers in the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, AD, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WY.
  To date there have been no confirmed illnesses.
  While AFC has ceased using the recalled ingredient, we urge anyone who has any AFC product containing Cooked Butterfly Tail-On Whiteleg Shrimp to discard or return product to their point of purchase for a full refund.
  Questions about the recall may contact AFC’s Recall Team at 866-467-8744 (Monday – Friday, 8:00 AM to 5:00 PM Pacific Time) or by email at recall@afcsushi.com.
• Sun Hong Foods, Inc 1105 W Olympic Blvd, Montebello, CA 90640 is recalling All Cases Enoki Mushroom (Product of Korea) Net Wt 7.05/200g because it has the potential to be contaminated with Listeria monocytogenes, a bacterium which can cause life-threatening illness or death. Consumers are warned not to even if it does not look or smell spoiled.
  Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
  Product was distributed (CA, TX, OR, WA, TX, IL, FL).
  Stores that maybe carry our brand: (Asian Supermarket), J&L Supermarket, Jusgo Supermarket, ZTao Market, New Sang Supermraket, Galleria Market.
  Enoki mushroom is packaged in a White Cardboard Box, inside has 25 count of 200g.
  Enoki mushrooms are white, with long stems and small caps. They’re usually sold in clusters. The affected products are sold in clear plastic bags with green panels: labeling in front of packaging will have 4 characters in korea, Enoki Mushrooms (orange front), Product of Korea, Net weight 7.05 oz/200g.
  UPC 7 426852 625810
  Brand name in back: Sun Hong Foods, Inc
  Packaging: 7.05 oz/200g
  Sold under refrigerated conditions
• American Health Packaging has voluntarily recalled eleven (11) lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters to the consumer level due to the potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. This recall was initiated in response to the recall by the manufacturer (Amneal Pharmaceuticals, LLC), which included affected lots that were repackaged by American Health Packaging.
  Risk Statement: NDMA is classified as a probable human carcinogen, a substance that can cause cancer, based on laboratory testing. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy and vegetables. No reports of injury or adverse events to date.
  Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis.
  American Health Packaging has not received any reports of adverse events that have been confirmed to be directly related to this recall.
  Product was distributed Nationwide to Wholesalers for use in hospital settings.
  Product Description
  AHP Lot No.
  Expiration Date
  AHP Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters
  Carton NDC#: 60687-322-01
  (Individual Dose NDC: 60687-322-11)
  179516
  12/31/2019
  179745
  12/31/2019
  180712
  02/29/2020
  180819
  04/30/2020
  181403
  05/31/2020
  182544
  05/31/2020
  183155
  05/31/2020
  183236
  05/31/2020
  185739
  12/31/2020
  186600
  12/31/2020
  186702
  12/31/2020
  American Health Packaging has notified its distributors by recall letter, sent November 20th, 2019, to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. American Health Packaging has arranged for return of all recalled products to lnmar Pharmaceuticals Services. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Instructions for returning recalled products are given in the recall letter. Pharmacies that have received the affected lot should contact (877) 475-5864 to receive a return packet. Hours of operation are 9:00 am – 5:00 pm, Eastern Standard Time (EST) Monday thru Friday.
  Any general questions regarding the return of this product please contact Inmar Pharmaceuticals Services at 800-967-5952 (option 1). Hours of operation are 9:00 am – 5:00 pm, EST Monday through Friday.
  Consumers who have Ranitidine Tablets, USP which are being recalled should stop using the product or with questions regarding this recall can contact Inmar Pharmaceuticals Services by 800-967-5952 (option 1). Hours of operation are 9:00 am – 5:00 pm, EST Monday through Friday.
  Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.
• Cargill’s animal nutrition business is conducting a voluntary recall of a single lot (382 bags, 50 lb each) of NutreBeef® Transition Pellet (MH) beef cattle feed because the product may contain mispackaged feed with elevated levels of monensin. The affected product was sold in Kansas and Texas. At elevated levels, monensin can be toxic to cattle and can cause colic-like symptoms, hypokalemia (low potassium), myoglobinuria (breakdown of muscle in the urine), chronic cardiovascular issues, and possible death.
  The following affected product was manufactured at Cargill’s McPherson, KS, facility and is being recalled from retail outlets and distributors in the Kansas and Texas markets.
  Product
  Size
  Lot Code
  Product Code
  UPC Code
  Species
  Dates Made
  Shelf Life (Days)
  NutreBeef®
  Transition Pellet
  (MH)
  Packaged in a plain brown paper bag
  50 lb Bags
  529316973
  Bottom left corner of feed label
  80652
  Bottom right
  corner of feed label
  722304442668
  Bottom right corner of feed label
  Beef Cattle
  11/12/19
  90 days
  Cargill received notification of this issue from a customer. Cargill immediately began an investigation and initiated a feed recall. To date, Cargill has received notification from one farm of eight animal deaths linked to this lot of feed.
  Consumers and other end users who have any of the affected lots in their possession should return remaining product to their local dealer or retailer for a replacement or full refund. For more information, call the Customer Service line at 1-800-542-0019, Monday – Friday, 8:00a.m. – 5:00p.m. EDT, or email McPherson_FeedOrder@Cargill.com.
• Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. Specifically, we are recalling the following lots: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022 and Rompe Pecho MAX lot 19B42, exp February 2022. These three lots have been found to containmicrobial contamination.
  In rare circumstances, consumption of Rompe Pecho from these lots could result in vomiting and diarrhea. Efficient Laboratories has not received any reports of adverse events to date.
  These products are used to treat symptoms of the flu and the common cold, and each are packaged in a box containing a bottle of the liquid product. The affected Rompe Pecho product lots are: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022 and Rompe Pecho MAX lot 19B42, exp February 2022. The lot numbers and expiration dates can be found on the bottom of the cartons. These Rompe Pecho products were distributed nationwide to wholesalers and retailers.
  Efficient Laboratories is notifying its distributors of these three lots by email and is arranging for the return or replacement of all recalled products.Consumers that have Rompe Pecho EX, Rompe Pecho CF, or Rompe Pecho MAX from these lots thatare being recalled should stop using these productsand discard or return them to the place of purchase.
  Consumers with questions regarding this recall can contact Efficient Laboratories by phone at (305) 805-3456, Monday through Friday from 9am to 4:30pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
• Salud Natural Entrepreneur, Inc. of Waukegan, IL is voluntarily recalling Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsule) products due to possible Salmonella contamination in one of the ingredients used on the formula of Nopalina Flax Seed Fiber. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. Consumers of these products who are experiencing symptoms of Salmonella should contact their health care provider. To date, there are no reports of illnesses associated with the products.
  Nopalina Flax Seed products are distributed throughout the United States and Puerto Rico via retail stores and the company’s web site https://www.nopalinaonline.com/
  External Link Disclaimer
  The following lot numbers are affected by this recall (the lot numbers can be found on the bottom back of the product label):
  Nopalina Flax Seed Fiber (powder, 1 lb. bags) UPC 890523000720
  Lot # 62.19 / 9 # 52.1 Best if used by 10/7/21
  Lot # 62.19 / 2 # 52.1 Best if used by 10/7/21
  Nopalina Flax Seed Fiber (powder, 1 lb. bags) UPC 890523000720
  Lot # 64.19 / 3 # 52.1 Best if used by 10/21/21
  Nopalina Flax Seed Fiber (powder, 1 lb. bags) UPC 890523000720
  Lot # 65.19 / 1 # 52.1 Best if used by 10/24/21
  Lot # 65.19 / 2 # 52.1 Best if used by 10/24/21
  Nopalina Flax Seed Fiber (powder, 2 lb. bags) UPC:890523000843
  Lot # 64.19 / 2 # 52.1 Best if used by 10/21/21
  Lot # 64.19 / 2 * 2Lb # 52.1 Best if used by 10/21/21
  Nopalina Flax Seed Fiber (capsules, 120 count) UPC 890523000867
  Lot # 23.19 1C120 # 07 Best if used by 10/7/21
  Lot # 23.192C120 # 02 Best if used by 10/7/21
  Lot # 23.19 / 2C120 # 02 Best if used by 10/7/21
  Lot # 23.19.2C120 # 02 Best if used by 10/7/21
  Lot # 23.19.3C120 # 02 Best if used by 10/7/21 Consumers who have purchased Nopalina Flax Seed Powder and Nopalina Flax Seed Capsules having the lot numbers listed above should not consume them and are urged to return it to the place of purchase for a full refund.
  Consumers with questions may contact the company at 877-296-6845 (Monday to Friday 9am-5pm) or can go to our site: https://www.nopalinaonline.com/certificate/
• Golden Pearl Trading Corporation (doing business as Dandy Food Products), a San Lorenzo, Calif. establishment, is recalling approximately 12,054 pounds of ready-to-eat (RTE) imported Siluriformes products that were not presented for import re-inspection into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Additionally, the products were imported from Singapore, a country ineligible to export ready-to-eat Siluriformes products to the U.S.
  The RTE salted egg fish skin items were imported on various dates on or around Sept. 26, 2019 through Dec. 24, 2019. The following products are subject to recall: [View Labels (PDF Only)]
  113-g. foil bags containing “Sugar Kid SALTED EGG FISH SKIN.”
  These items were shipped to distributors and retail locations in California, Hawaii, Nevada, New York, Oregon, Utah and Washington.
  The problem was discovered during a routine FSIS surveillance activity of imported products.
  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
  FSIS is concerned that consumers may still be in possession of the product. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
  FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers. When available, the retail distribution list will be posted on the FSIS website at http://www.fsis.usda.gov/recalls.
  Consumers and members of the media with questions about the recall can contact Robert Moore, Managing Director of Golden Pearl Trading Corporation, at (408) 836-7923 or at Robert@dandyfood.com.
• Amity Packing Company Inc., a Chicago, Ill. establishment, is recalling approximately 2,020 pounds of raw ground beef products that may be contaminated with extraneous materials, specifically clear, thin pliable plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
  The raw ground beef items were produced on Jan. 6, 2020. The following products are subject to recall: [View Labels (PDF only)]
  1-lb. VACUUM-PACKED, packages containing “Pre 95% LEAN/5% FAT GROUND BEEF” with lot code “0060,” case code “11402” and USE/FREEZE BY date of “01/31/2020” on the product label.
  The products subject to recall bear establishment number “EST. 6916” printed on the right, front side of the package. These items were shipped to retail locations in Illinois, Indiana, Kentucky, Michigan, New Jersey, New York, Ohio, Pennsylvania and Wisconsin.
  The problem was discovered after Pre Brands LLC. received two consumer complaints reporting findings of clear, thin pliable plastic in raw ground beef.
  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
  FSIS is concerned that some product may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
  FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.
  Consumers with questions about the recall can contact Pre Brands LLC. at 1-844-773-3663. Members of the media with questions about the recall can contact Nicole Schumacher, Pre Brands LLC., Chief Marketing Officer, at (312) 837-3812 or at NSchumacher@eatpre.com.
• Northern FishFive Star Food Inc, Garden City, MI is recalling 100 cases of Excellent tahina 800 g and 100 cases of excellent tahina 400 g containers because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.The product was distributed in states of Michigan, Ohio, New York, Florida, North Dakota, Virginia, Pennsylvania, and Texas and is sold in 800 grams (1.76 lb) and in 400 grams (14.1 oz). Expiration dates (Best By Nov 2020) are printed on the lid of the container.Product Code Product Description UPC Expiration
  TAH806SG Excellent Tahina 800 g 6214002717420 Best By Nov 2020
  TAH400SG Excellent Tahina 400 g 6214002717413 Best By Nov 2020No illnesses have been reported to-date in connection with the Sham Gardens Tahini.This potential problem was revealed as a result of a random sampling by the Michigan Department of Agriculture and Rural Development. Although we have not received the final laboratory reports, Five Star Foods is taking the precaution of recalling product with the product code listed above.Consumers who have purchased Sham Gardens Tahini with these codes should discontinue use and return it to the store of purchase for a full refund. Retailers that may have further distributed the recalled codes should share this notice with their customers. Retailers or consumers with questions may contact Recall Coordinator Mr. Omar at 810-919-3519 Monday to Friday from 9AM – 5PM.
• This is to inform you that ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. (the “COMPANIES”) is conducting a nationwide recall of ALL lots of its dietary supplement products pursuant to a Consent Decree entered by the U.S. District Court for the Eastern District of New York. This recall applies to all dietary supplement products manufactured and sold between January 2013 – November 2019 and all lots of products are included in this recall.
  These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations. Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process resulting in finished supplement products with decreased identity, purity, strength and composition.
  To date, there have been no reported illnesses or injuries as a result of this situation.
  The COMPANIES contract manufactured dietary supplements for other firms and did not sell products directly to consumers.
  Consumers should check the attached list of companies who distributed the dietary supplements to determine if they have purchased a recalled product that needs to be returned or destroyed.
  The COMPANIES are notifying its distributors and customers via email and is arranging for return of all recalled products. Wholesalers and distributors (direct customers of the COMPANIES) that have any dietary supplement products manufactured or packaged at the Edgewood, NY facility being recalled should contact a representative of the COMPANIES for instructions with regard to returning any remaining stock.
  Distributors or Consumers with questions regarding this recall can contact a representative of the COMPANIES by phone at (866) 922-4669 or e-mail recall@abhnutra.com, Monday – Friday, 9:00am – 4:30pm, EST.
• Lipari Foods is expanding its January 6, 2020 and January 13, 2020 recalls of Premo and Fresh Grab sandwiches to include all sandwiches with a Best By date of 2/6/20 and prior, due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.
  The products were distributed exclusively by Lipari Foods in Warren, Michigan to food service and retail stores throughout Alabama, Florida, Iowa, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Tennessee, West Virginia, and Wisconsin.
  All affected products subject to this recall can be identified by:
  Brand
  Product
  Lipari #
  Size
  Best By Date
  UPC
  Premo
  Italian Footlong Sandwich
  996431
  8 oz.
  01/08/20 – 02/02/20
  612510093535
  Premo
  Turkey & Cheese on a Pretzel Sub Bun
  996428
  7 oz.
  01/09/20 – 02/03/20
  612510094037
  Premo
  Ham & Cheese on a Hawaiian Bun
  996425
  6 oz.
  01/02/20 – 01/27/20
  612510093511
  Premo
  Meat Lovers Sub
  970844
  7 oz.
  01/07/20 – 02/01/20
  612510093832
  Premo
  Bologna & Cheese Wedge Sandwich
  920220
  5 oz.
  01/12/20 – 02/06/20
  612510093306
  Premo
  Tuna Salad Wedge Sandwich
  915579
  5 oz.
  01/12/20 – 02/06/20
  612510002049
  Premo
  Tuna Salad Wedge Sandwich
  293672
  5 oz.
  01/12/20 – 02/06/20
  612510002049
  Premo
  Chicken & Swiss Cheese Sandwich
  915572
  5 oz.
  01/09/20 – 02/03/20
  612510003213
  Premo
  Chicken & Swiss Cheese Sandwich
  208004
  5 oz.
  01/09/20 – 02/03/20
  612510003213
  Premo
  Pub Burger with Cheese
  915565
  5 oz.
  01/09/20 – 02/03/20
  612510003015
  Premo
  Pub Burger with Cheese
  207970
  5 oz.
  01/09/20 – 02/03/20
  612510003015
  Premo
  Asiago Italian Sub Sandwich
  915558
  6 oz.
  01/09/20 – 02/03/20
  612510001196
  Premo
  Asiago Italian Sub Sandwich
  207919
  6 oz.
  01/09/20 – 02/03/20
  612510001196
  Premo
  King Club Footlong Sub Sandwich
  915551
  9 oz.
  01/09/20 – 02/03/20
  612510001080
  Premo
  Ham & Provolone Sub Sandwich
  915544
  6 oz.
  01/09/20 – 02/03/20
  612510001059
  Premo
  Ham & Provolone Sub Sandwich
  207851
  6 oz.
  01/09/20 – 02/03/20
  612510001059
  Premo
  Turkey & Swiss Cheese Sub Sandwich
  915537
  6 oz.
  01/09/20 – 02/03/20
  612510001042
  Premo
  Turkey & Swiss Cheese Sub Sandwich
  207834
  6 oz.
  01/09/20 – 02/03/20
  612510001042
  Premo
  Chicken Salad Wedge Sandwich
  915530
  5 oz.
  01/12/20 – 02/06/20
  612510002032
  Premo
  Chicken Salad Wedge Sandwich
  207715
  5 oz.
  01/12/20 – 02/06/20
  612510002032
  Premo
  Egg Salad Wedge Sandwich
  915523
  5 oz.
  01/12/20 – 02/06/20
  612510002025
  Premo
  Egg Salad Wedge Sandwich
  207698
  5 oz.
  01/12/20 – 02/06/20
  612510002025
  Premo
  Turkey & Cheese Wedge Sandwich
  915516
  5 oz.
  01/12/20 – 02/06/20
  612510002018
  Premo
  Turkey & Cheese Wedge Sandwich
  207681
  5 oz.
  01/12/20 – 02/06/20
  612510002018
  Premo
  Ham & Cheese Wedge Sandwich
  915509
  5 oz.
  01/12/20 – 02/06/20
  612510002001
  Premo
  Ham & Chipotle Mayo on Glazed Roll
  915495
  6 oz.
  01/07/20 – 02/01/20
  612510088500
  Premo
  Ham & Chipotle Mayo on Glazed Roll
  207456
  6 oz.
  01/07/20 – 02/01/20
  612510088500
  Premo
  Turkey & Garlic Mayo on Split-Top Roll
  915488
  6 oz.
  01/07/20 – 02/01/20
  612510088494
  Premo
  Turkey & Garlic Mayo on Split-Top Roll
  207455
  6 oz.
  01/07/20 – 02/01/20
  612510088494
  Fresh Grab
  Turkey & Provolone with Garlic Mayo
  455956
  6 oz.
  01/07/20 – 02/01/20
  612510090435
  Fresh Grab
  Ham & Cheddar with Chipotle Mayo
  455939
  6 oz.
  01/07/20 – 02/01/20
  612510090428
  Fresh Grab
  Tuna Salad Wedge Sandwich
  282022
  5 oz.
  01/12/20 – 02/06/20
  612510002049
  Fresh Grab
  Ham & Cheese on White Wedge Sandwich
  253479
  5 oz.
  01/12/20 – 02/06/20
  612510093962
  Fresh Grab
  Turkey No Cheese Wedge Sandwich
  253445
  5 oz.
  01/12/20 – 02/06/20
  612510002100
  Fresh Grab
  Chicken Salad Wedge Sandwich
  253377
  5 oz.
  01/12/20 – 02/06/20
  612510002032
  Fresh Grab
  Egg Salad Wedge Sandwich
  252901
  5 oz.
  01/12/20 – 02/06/20
  612510002025
  Fresh Grab
  Turkey & Cheese Wedge Sandwich
  252782
  5 oz.
  01/12/20 – 02/06/20
  612510002018
  Fresh Grab
  Ham & Cheese Wedge Sandwich
  252646
  5 oz.
  01/12/20 – 02/06/20
  612510002001
  Fresh Grab
  Chicken Buddies
  252595
  7 oz.
  01/09/20 – 02/03/20
  612510003602
  Fresh Grab
  Chicken Sandwich
  252527
  3.5 oz.
  01/09/20 – 02/03/20
  612510007020
  Fresh Grab
  Ham & Cheese Sandwich
  252493
  3.5 oz.
  01/09/20 – 02/03/20
  612510007006
  Fresh Grab
  Chicken & Swiss Cheese Sandwich
  252204
  5 oz.
  01/09/20 – 02/03/20
  612510003213
  Fresh Grab
  Breakfast Muffin
  252153
  6 oz.
  01/09/20 – 02/03/20
  612510003039
  Fresh Grab
  Smoked Turkey Sandwich
  251898
  6 oz.
  01/09/20 – 02/03/20
  612510007204
  Fresh Grab
  Asiago Italian Sub Sandwich
  251847
  6 oz.
  01/09/20 – 02/03/20
  612510001196
  Fresh Grab
  Club Sub Sandwich
  251796
  6 oz.
  01/09/20 – 02/03/20
  612510001165
  Fresh Grab
  Ham & Provolone Sub Sandwich
  251745
  6 oz.
  01/09/20 – 02/03/20
  612510001059
  Fresh Grab
  Turkey & Swiss Cheese Sub Sandwich
  251694
  6 oz.
  01/09/20 – 02/03/20
  612510001042
  Fresh Grab
  Ham & Swiss on Pretzel Sub Bun
  251626
  6 oz.
  01/09/20 – 02/03/20
  612510001028
  Premo
  Turkey, Bacon, & Cheddar Ciabatta Sandwich
  226442
  6 oz.
  01/07/20 – 02/01/20
  612510007815
  Premo
  Italian Ciabatta Sandwich
  226323
  6 oz.
  01/07/20 – 02/01/20
  612510007808
  Premo
  Pesto Chicken Ciabatta
  226272
  6 oz.
  01/07/20 – 02/01/20
  612510007228
  This recall was brought to our attention by JLM, who is further expanding their recent recall to include additional sandwiches with additional Best Buy dates due to potential contamination of Listeria monocytogenes. The company has ceased production at the producing facility while continuing to work in close collaboration with the FDA to further investigate the issue. No illnesses have been reported to date in relation to this recall.
  Lipari Foods began shipping this product on December 20, 2019
  Consumers who have purchased these recalled products should not consume them. Consumers should discard the products or return them to the point of purchase. Consumers with questions should call Customer Service at 800-729-3354, 8:15 am – 4:30 pm, EST, Monday through Friday.
•  TOPIC: FDA Recommends Transition to Duodenoscopes with Innovative Designs: FDA Safety CommunicationAUDIENCE: Patient, Gastroenterology, Health Professional, Risk ManagerISSUE: These devices have complex designs that include reusable hard-to-clean components. Failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient remaining in a duodenoscope when it is used on a subsequent patient. In rare cases, this can lead to patient-to-patient disease transmission.BACKGROUND: Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts and are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures in the United States each year.RECOMMENDATION:
  Patients: Important Recommendations
  • Be aware that the risk of infection from inadequate reprocessing is relatively low.
  • Do not cancel or delay any planned procedure without first discussing the benefits and risks with your health care provider.
  FDA General Recommendations:
  • FDA is now recommending that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes to those with newer design features that facilitate or eliminate the need for reprocessing. Please note, the FDA recognizes that a full transition away from conventional duodenoscopes to the newer, innovative models will take time.
  • FDA continues to work with manufacturers to increase the supply of disposable cap duodenoscopes and the development of other new and innovative device designs that will further minimize or eliminate the risk of patient infection.
  • FDA continues to address challenges with current reprocessing methods and support expanding the types of validated methods available to reprocess duodenoscopes.Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
• 1/8 Mavidon is notifying customers, we are amending our recall and have removed Collodions, Collodion Remover, Medical Adhesive Remover and Acetone from the recall.
  Hospital and clinics to STOP using LemonPrep, Pedia Prep, Wave Prep, Cardio Prep manufactured by Mavidon in the Riviera Beach, FL Facility IMMEDIATELY due to potential contamination with Burkholderia cepacia.
  Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep single use cups due to potential contamination with Burkholderia cepacia. We were notified on December 19, 2019 that samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection that occurred at our facility on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Out of an abundance of caution, we are recalling all products manufactured at our facility.
  Actions to be taken:
  Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it.
  Fill out the Medical Device Recall form below and email it to CS@mavidon.com
  We will follow up and give instructions on how to return the product for credit
  Burkholderia cepacia is a multi-drug resistant pathogenic microorganism. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threatening for patients with compromised immune systems, such as neonates, elderly, pregnant women, cancer patients, but also in previously healthy individuals. To date, Mavidon has received one report of adverse event in a neonate related to this product in recall.
  Mavidon is notifying of all of its customers by email and phone of this recall. Contact Mavidon at 800-
• • 119-2019, Ruiz Food Products, Inc. Recalls Frozen Sausage Breakfast Burrito Products due to Possible Foreign Matter Contamination(Dec 10, 2019)
•         TOPIC: LIFEPAK 15 Monitor/Defibrillators by Stryker: Recall – Due to failure to deliver a defibrillation shock after the “Shock” button on the keypad is pressedBACKGROUND: LIFEPAK 15 is a complete acute cardiac care response system designed for basic life support and advanced life support patient management protocols.ISSUE: Stryker is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed. This is a result of oxidation that may have formed over time within the “Shock” button.Stryker is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad. Stryker anticipates that all devices subject to this field action will be serviced by June 2021.RECOMMENDATION: Stryker is instructing customers to continue to use their LIFEPAK 15 monitor/defibrillator according to the operating instructions until the correction can be completed. Customers should continue to perform the daily check as described in the Operator’s Checklist, specifically, the QUIK- COMBO therapy cable check as described in the General Maintenance and Testing Section (pages 10-4 and the LIFEPAK 15 monitor/defibrillator Operator’s Checklist, number 7).Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
• Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot of Lamotrigine 100 mg Tablets Lot #331771 (expiration date June 2021) was found to have been cross-contaminated with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility.
  This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200110005522/en/
  External Link Disclaimer
  Risk Statement: Use of Lamotrigine 100 mg Tablets could potentially result in exposure to a small amount of Enalapril Maleate, if present in the product in question. Enalapril Maleate is a drug substance indicated for hypertension and congestive heart failure. There is potential with chronic exposure to Enalapril Maleate to impact users particularly if they are small children or pregnant women. Enalapril Maleate is also associated with risk of birth defects in a developing fetus. Therefore, there is risk associated with the continued, long-term use of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021).
  Taro has not received any product complaints or adverse events related to contamination of this product with Enalapril, or any complaints or adverse events that are associated specifically with this recall. Taro will continue to actively monitor for any and all adverse event reports that may be received, in compliance with FDA regulatory requirements.
  Lamotrigine 100 mg Tablets are indicated for Epilepsy and Bipolar disorder. This product is packaged in white plastic bottles with screw cap closure, and each bottle contains 100 tablets. Each bottle is labeled to indicate the name of the product, Lamotrigine Tablets USP, 100 mg, the NDC #51672-4131-1 (see image of container label below), the lot number 331771 and expiration date of June 2021.
  Lamotrigine 100 mg Tablets, Lot # 331771 were distributed to wholesale distributors in the US market between August 23 and August 30, 2019. These wholesale customers may have further distributed Lot # 331771 to retail pharmacies for prescription dispensing to patients who were prescribed 100 mg Lamotrigine Tablets.
  Taro is notifying its distributors and customers by Phone, E-mail, and Letters via US Mail and is arranging for return of any containers or quantities of Lamotrigine 100 mg Tablets, Lot # 331771 (exp. June 2021). Consumers that have any quantities of Lamotrigine 100 mg Tablets, Lot # 331771 being recalled should stop using this product and return it to the pharmacy that dispensed it. Retailers, pharmacies and distributors should stop distributing or dispensing this product and return it to Taro.
  Consumers with questions regarding this recall can contact Taro by calling 1-866-923-4914 or by e-mail at TaroPVUS@taro.com, Monday through Friday between 7:00 AM and 7:00 PM US Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
• Lipari Foods has issued a voluntary recall of various Premo and Fresh Grab wedge sandwiches due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.
  The product was distributed exclusively by Lipari Foods in Warren, Michigan to food service and retail stores throughout Florida, Illinois, Indiana, Kentucky, Maryland, Michigan, Ohio, Pennsylvania, Tennessee, West Virginia, and Wisconsin.
  The affected product can be identified by:
  Brand
  Product
  Lipari #
  Size
  Best By Date
  Lot #
  UPC
  Premo
  Wedge Ham & Cheese On Wheat
  915509
  5 oz.
  1/23/2020
  31201912
  612510002001
  Premo
  Wedge Egg Salad On Wheat
  915523
  5 oz.
  1/23/2020
  31201912
  612510002025
  Premo
  Wedge Chicken Salad On Wheat
  915530
  5 oz.
  1/20/2020
  31201912
  612510002032
  Premo
  Wedge Tuna Salad On Wheat
  915579
  5 oz.
  1/23/2020
  31201912
  612510002049
  Fresh Grab
  Wedge Ham/American On Wheat
  252646
  5 oz.
  1/23/2020
  31201912
  612510002001
  Fresh Grab
  Wedge Egg Salad On Wheat
  252901
  5 oz.
  1/20/2020, 1/23/2020
  31201912
  612510002025
  Fresh Grab
  Wedge Chicken Salad On Wheat
  253377
  5 oz.
  1/23/2020
  31201912
  612510002032
  Fresh Grab
  Wedge Tuna Salad On Wheat
  282022
  5 oz.
  1/23/2020
  31201912
  612510002049
  Fresh Grab
  Wedge Turkey No Cheese On Wheat
  253445
  5 oz.
  1/23/2020
  31201912
  612510002100
  Fresh Grab
  Wedge Ham/American On White
  253479
  5 oz.
  1/23/2020
  31201912
  612510093962
  This was brought to our attention by JLM Manufacturing after environmental sampling returned a positive test result for Listeria monocytogenes. No illnesses have been reported to date in relation to these products or recall.
  Lipari Foods began shipping this product on December 31, 2019.
  Consumers who have purchased these recalled products should not consume them. Consumers should discard the products or return them to the point of purchase. Consumers with questions should call Customer Service at 800- 729-3354, 8:15 am – 4:30 pm, EST, Monday through Friday.
• Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. To date, Appco has not received any reports of adverse events related to use of the product as part of this recall.
  Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
  Ranitidine Hydrochloride in strengths of 150 mg and 300 mg, is a prescription-only oral medication indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable.
  The products subject to recall are listed below and are packaged in bottles. The product can be identified by checking the product name, count/bottle, manufacturer details and batch or lot number on the bottle containing these products.
  Description
  Strength
  NDC
  Batch #
  Counts
  Expiration date
  Ranitidine Capsules 300 mg
  300 mg
  62559-691-30
  1905227UE
  30’s
  Apr-21
  300 mg
  62559-691-30
  1905228UE
  30’s
  Apr-21
  Ranitidine Capsules 150 mg
  150 mg
  62559-690-60
  1905225VN
  60’s
  Apr-21
  150 mg
  62559-690-05
  1905226VD
  500’s
  Apr-21
  150 mg
  62559-690-60
  1906295UN
  60’s
  May-21
  150 mg
  62559-690-60
  1906296UN
  60’s
  May-21
  150 mg
  62559-690-60
  1906297UN
  60’s
  May-21
  150 mg
  62559-690-05
  1906298UD
  500’s
  May-21
  Ranitidine Capsules 150 mg & Ranitidine Capsules 300 mg were distributed nationwide.
  Appco is notifying their marketing partner (ANI Pharmaceuticals, Inc.) by phone, email or other communication with recall notification communication. ANI Pharmaceuticals Inc., on behalf of Appco Pharma LLC, will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Appco is arranging for return of all recalled products to ANI Pharmaceuticals, Inc. Instructions for returning recalled products are given in the recall letter. Anyone with an existing inventory will be asked to immediately stop distribution and return any stock to ANI Pharmaceuticals, Inc. by contacting Stephen Bitter at stephen.bitter@anipharmaceuticals.com or 218-634-3655 (between 8 to 5PM CST). All the recalled product shall be sent to:
  ANI Pharmaceuticals
  Attn: Stephen Bitter
  210 Main Street West
  Baudette, MN 56623
• Mylan N.V.
  External Link Disclaimer
  (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse events related to these batches to date, this product is being voluntarily recalled due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited.
  NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).
  The finished products are manufactured by Mylan Pharmaceuticals Inc. These batches were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018. The recalled batches are as follows:
  NDC
  Product Description
  Strength
  Size
  Lot Number
  Expiry
  0378-5150-91
  Nizatidine Capsules, USP
  150mg
  Bottles of 60
  3086746
  May 2020
  0378-5300-93
  Nizatidine Capsules, USP
  300mg
  Bottles of 30
  3082876
  Jan 2020
  0378-5300-93Nizatidine Capsules, USP300mgBottles of 303082877Jan 2020Nizatidine is indicated for the short-term treatment (up to 8 weeks) of active duodenal ulcers and active benign gastric ulcers, as maintenance therapy for duodenal ulcer patients for up to one year, and for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).
  Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 888-628-0727 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.
• Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. The recall is in response to the manufacturer’s recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, which were repackaged by Denton Pharma, Inc. dba Northwind Pharmaceuticals. To date, Northwind has not received any reports of adverse events that have been confirmed to be directly related to this recall.
  Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables.
  The Ranitidine Tablets, USP, distributed by Northwind are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
  The Ranitidine Tablets, USP, subject to the recall can be identified by the NDC number on the product label. The following NDCs of Ranitidine Tablets, USP, 150 mg and 300 mg, are included in this recall:
  Product
  NDC
  Ranitidine Tablets, USP 150mg
  70934-017-04
  70934-017-20
  70934-017-24
  70934-017-30
  70934-017-90
  Ranitidine Tablets, USP 150mg
  70934-017-04
  70934-017-20
  70934-017-24
  70934-017-30
  70934-017-90
  The affected Ranitidine Tablets were distributed directly to Northwind Pharmaceuticals, LLC and Crosswind Pharmacy.
  The 150mg products product are packaged in unit of use bottle packs of 4’s, 20’s, 24’s, 30’s, and 90’s, whereas, the 300mg product are packaged in unit of use bottle packs of 15’s and 90’s. Photos are attached below.
  Northwind is notifying its direct customers with a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lot immediately. Northwind is committed to product and consumer safety. It will continue to fully cooperate with the FDA as the agency evaluates ranitidine products for the presence of NDMA above established limits and formulates guidance for ranitidine manufacturers. As a further precautionary measure, Northwind ceased distribution of its Ranitidine products in the United States while the manufacturer continues its efforts to test and investigate in cooperation with the FDA.
  Customers who purchased the impacted product directly from Northwind can call Northwind at 1-800-722-0772 Monday – Friday, 9:00 am – 5:00 pm, EST to arrange for product return.
• Fresh Location, of Lenoir City, Tennessee is recalling:
  Protein Snack Tray 6.44 oz total weight packaged in a 4-compartment plastic tray with UPC: 8-5511000804-6 and with Fresh by lot dates of: 12/21/19, 12/22/19, 12/24/19, 12/27/19, 12/28/19, 12/29/19, 12/31/19, 01/03/20, 01/04/20
  Protein Trail Mix 3.52 oz total weight packaged in a 10.5 ounce plastic cup with UPC: 8-5511000813-8 and with Fresh by lot dates of: 12/23/19, 12/24/19, 12/26/19, 12/29/19, 12/30/19, 12/31/19, 01/02/20, 01/05/20, 01/06/20
  Due to possible contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, we have not received any reports of illness related to the consumption of our Protein Snack Tray or Protein Trail Mix
  Almark Foods which manufactures the Hard-Boiled at the Gainesville facility may be associated with a Listeria monocytogenes outbreak that has been linked to several reported illnesses and one reported death.
  Affected product could have been delivered in the following states through convenience stores, micro markets, hospitals, hotels and vending machines: Illinois, Missouri, Tennessee, Georgia, South Carolina, North Carolina, Kentucky, Virginia, Indiana, and Mississippi.
  Consumers who have purchased the affected product are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-865-717-6800 Monday – Friday 8:00 AM ET to 5:00 PM ET.
• Veggie Noodle Co., LLC is voluntarily recalling its Cece’s® Veggie Co. brand Fresh Veggie Ramen with Chicken Broth (11.5 oz, UPC 5228700653), all expiration dates, sold at retail stores nationally, because the separately packaged egg ( branded Peckish) that is included in the product has the potential to be contaminated with Listeria monocytogenes. No other Cece’s brand products are subject to this recall. Veggie Noodle is issuing this voluntary recall out of an abundance of caution, due to a recall by a provider of the eggs, Almark Foods, used in the product.
  Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
  Veggie Noodle has received no reports of illness associated with the recalled Fresh Veggie Ramen with Chicken Broth product. No other Veggie Noodle/Cece’s products are affected by the recall, and may be consumed.
  An illness outbreak appears to be associated with eggs supplied by Almark Foods that were ingredients in foods produced by other companies.
  Veggie Noodle contacted all affected customers to confirm that the recalled product has been removed from store shelves.
  Consumers who have purchased any recalled product are urged not to consume it, but to discard or return it to the place of purchase for a full refund. Consumers with further questions may call Veggie Noodle at (512) 200-3337 (Monday to Friday, 9 AM to 5 PM Central) or by email at info@cecesveggieco.com.
• Limena, LLC of Palm Springs, FL. is recalling its 1 lb. (16 ounce) blocks of Salvadorean String Cheese (Quesillo Cheese) semi-soft cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
  The recalled “Salvadorean String Cheese (Quesillo Cheese)” was distributed to retail stores and through mail orders.
  The product has a blue and white label and comes in a 1 lb. (16 oz.), clear plastic vacuum package marked with lot #1041020 on the top. The Expiration date is blank.
  No illnesses have been reported to date in connection with this problem.
  The potential for contamination was noted after routine testing by the Florida Department of Agriculture and Consumer Services revealed the presence of Listeria monocytogenes in one sample of 1 lb. (16 ounce) blocks of Salvadorean String Cheese (Quesillo Cheese).
  The production of the product has been suspended while FDA and the company continue to investigate the source of the problem.
  Consumers who have purchased the 1 lb. block of Salvadorean String Cheese (Quesillo Cheese) are urged to discard the product. Consumers with questions may contact the company at (561) 541-5206, M-F, 8 am – 6 pm EST.
• Dianne’s Fine Desserts of Newburyport, MA 01950 is recalling twenty six cases of product Sienna Turtle Brownie 849-524-1115 lot code 19198 , because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
  Sienna Turtle Brownie 8495241115 lot code 19198 was distributed through retail wholesale clubs located in MI, IL, IN.
  Sienna Turtle Brownie 8495241115 lot code 19198 can be identified by the name and product image on the tray. Tray size 17.1875×13.125×2, Lot code 19198 can be found on the top and or bottom of tray side panel.
  No illnesses have been reported to date.
  The recall was initiated after it was discovered that product containing peanuts was distributed in packaging that did not reveal the presence of peanuts. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging processes.
  Consumers who have purchased Sienna Turtle Brownie 8495241115 lot code 19198 are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Monday- Friday 9am-5pm EST:
• FiveStar Gourmet Foods takes issues of food safety seriously and in an abundance of caution is voluntarily recalling two fresh produce snack products, MiniMeal2Go-ProteinPack 8.25oz and MiniMeal2Go- AvocadoToast 6.75oz. due to the notification from Almark Foods of Gainesville, GA that Almark Foods may have supplied single-serve prepackaged Hard Boiled Eggs contaminated with Listeria monocytogenes and its association with a current foodborne illness investigation.
  The MiniMeal2Go products were distributed in Illinois, Indiana, Kentucky, Ohio, Michigan and Wisconsin in Meijer supermarkets only. Both MiniMeal2Go products come in a 6/8.25-ounce and 6/6.75-ounce clear plastic package marked with specific lots (see chart) with an expiration dates from 12/26/19 through 1/06/20 printed on the film.
  No other FiveStar items are involved with this voluntary recall. There are no reported illnesses to date related to the FiveStar Gourmet Foods products.
  Consumers who purchased products listed in the chart below from the affected sell by dates or with an unreadable date code are urged not to consume them and to throw the products away. For any questions, consumers may contact FiveStar Gourmet Foods at 877-546-8763 (Mon-Fri 8:00 am to 4:30 pm PST) for the most up-to-date information.
  Retailer
  Brand
  Item Name
  Package Weight
  Item SKU
  UPC #
  Lot No
  States Affected
  Best By
  Meijer
  MiniMeals2Go
  Protein Pack
  6/8.25oz
  FG10461
  8-
  50012-
  79311-3
  34619,34719,
  35019,35119,
  35219,35719
  Illinois, Indiana, Kentucky, Michigan, Ohio,
  Wisconsin
  12/26/19,12/27/19,
  12/30/19,12/31/19,
  01/01/20,01/06/20
  Meijer
  MiniMeals2Go
  Avocado Toast
  6/6.75oz
  FG10463
  8-
  50012-
  79315-1
  34619,34719,
  35019,35119,
  35219,35719
  Illinois, Indiana, Kentucky, Michigan, Ohio,
  Wisconsin
• As part of a multi-state recall due to the potential risk of Listeria monocytogenes, Meijer – in conjunction with Almark Foods – is announcing a voluntary recall of frozen hard-boiled egg products used on two salad bars at two stores in Grand Rapids, Mich.Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as igh fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.Meijer is recalling the following products:UPC – 79379900993 – DICED EGGS FROZEN 5 LBThe multi-state recall involves product potentially sold between Oct. 25, 2019 and Dec. 23, 2019 at two stores in Grand Rapids, Mich. There have been no illnesses reported to date. Store locations are:The Knapps Corner Meijer at 1997 East Beltline Road in Grand Rapids, Mich.
  The Rockford Meijer at 2799 10 Mile Road NE in Rockford, Mich.Almark Foods issued the initial recall, in cooperation with the U.S. Food & Drug Administration, out of an abundance of caution to its customers. Meijer used the hard-boiled egg ingredients on its salad bars which originated from Almark Foods.
• Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.
  Taking a higher dose than expected, may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults.
  Mirtazapine tablets are indicated for the treatment of major depressive disorder and are packaged in 500 count bottles. The affected lot number for both Mirtazapine Tablets 7.5 mg and Mirtazapine Tablets 15 mg are 03119002A3 Exp 03/2022. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
  Aurobindo Pharma USA, Inc. is notifying its distributors by letter and is arranging for return of all of the recalled product. Distributors/retailers that have product which is being recalled should return the bottle(s) to place of purchase.
  Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:
  1-866-850-2876 Option 2
  pvg@aurobindousa.com
• Almark Foods has recalled all products using boiled eggs produced at its facility in Gainesville, Georgia. Sven Hoppe / picture alliance via Getty Images
  Hard-boiled eggs from a production facility in Georgia have been recalled after being linked to an ongoing listeria outbreak.
  The recall spans products from over 30 brands sold at stores like Trader Joe’s, Costco, Walmart, and Kroger.
  So far, the listeria outbreak has resulted in seven reported infections across five states and one reported death.
  The Centers for Disease Control and Prevention advises that people especially vulnerable to listeria infection discard any store-bought products containing hard-boiled eggs.
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• J&J Distributing, a St. Paul, Minn. establishment, is recalling approximately 136 pounds of ready-to-eat salad products that contain meat due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain pine nuts (tree nut), a known allergen, which is not declared on the product label.
  The ready-to-eat salad products that contain meat were produced on various dates from December 21, 2019 through December 27, 2019. The following products are subject to recall: [View Labels (PDF only)]
  14-oz. plastic sealed cartons containing “KOWALSKI’S MARKETS SICILIAN CHOPPED SALAD” with a “SELL BY” sticker placed on the carton with dates of 12/27 through 01/02 (inclusive).
  14-oz. plastic sealed cartons containing “KOWALSKI’S MARKETS ITALIAN STEAKHOUSE COBB SALAD” with a “SELL BY” sticker placed on the carton with dates of 12/27 through 01/02 (inclusive).
  The products subject to recall bear establishment number “EST. 38450” inside the USDA mark of inspection. These items were shipped to retail locations in Minnesota.
  The problem was discovered during routine FSIS inspection activities.
  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
  FSIS is concerned that some product may be in consumers’ refrigerators. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
  FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at http://www.fsis.usda.gov/recalls.
  Consumers and members of the media with questions about the recall can contact Ron Carkoski, CEO of J&J Distributing, at (651) 292-3822.

The New York Times Archives

LONDON, April 30 — Representatives of British West Indian colonies formally announced today that they had agreed upon the formation of a British Caribbean Federation which is intended to become eventually a new self-governing unit in the British Commonwealth.

for more:  nytimes.com/1953