FDA/USDA- June ~2019~ Alerts & Safety


 

 

  • Fresenius Kabi USA, LLC is voluntarily recalling two lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, to the user level due to the potential for glass particulate. The affected lots, distributed between December 6, 2018 and February 20, 2019, are listed below:

Product Name/Size
NDC Number
Product Code
Lot Number
Expiration Date
First Ship Date
Last Ship Date
Fluorouracil Injection,
USP, 5g/100mL (50mg/mL), 100mL
fill in a 100mL vial
63323-117-69
NP101761
6120341
04-2020
12/06/2018
12/18/2018
63323-117-61
101761
6120420
04-2020
12/07/2018
02/20/2019
Products containing glass particulate should not be administered intravenously due to the potential for life-threatening consequences. Reports in the literature suggest that sequelae of thromboembolism, such as pulmonary emboli, phlebitis, granulomas, or fibrosis may occur.
To date, Fresenius Kabi has not received any complaints or reports of adverse events related to this recall.
The company is issuing this notification after finding glass particulate in five vials in retained sample inventory of lot 6120341 during an inspection for a quality investigation. The second lot (6120420) is included in the recall as a precautionary measure as it was produced in the same filling campaign.
Fluorouracil is a chemotherapy drug that is administered intravenously and indicated for the treatment of a variety of cancers.
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
External Link Disclaimer

External Link Disclaimer
kabi.com/us/pharmaceutical
External Link Disclaimer
Consumers with questions regarding this recall may contact Fresenius Kabi at 1-800-551-7176 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. or via email at productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@freseniuskabi.com 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.
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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit http://www.fresenius
External Link Disclaimer

External Link Disclaimer
kabi.com

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  • Growers Express takes issues of food safety seriously and is issuing a voluntary recall of select fresh vegetable products in an abundance of caution and in the interest of protecting its customers and end consumers. The fresh vegetable products include packaged varieties of butternut squash, cauliflower, zucchini and a butternut squashed based veggie bowl. Please refer to the detailed chart below for specific product names and retailers.
    The products originate from a Growers Express production facility in Biddeford, Maine and were distributed to the states referenced in the chart below. The voluntary recall was issued due to the potential for contamination with Listeria monocytogenes. There are no reported illnesses.
    Listeria is an organism that 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 short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.
    Most of the affected products are labeled with a “Best If Used By” Date of June 26 – June 29, 2019. No other Growers Express products are impacted or part of this recall. This recall does not affect or include any Green Giant® canned or frozen vegetable products.
    “The safety of our consumers is our first priority,” said Tom Byrne, President of Growers Express. “We selfreported the need for this recall to the U.S. Food and Drug Administration (FDA) and stopped production immediately after being notified of a single positive sample by the Massachusetts Department of Health. We are deep sanitizing the entire facility and our line equipment, as well as conducting continued testing on top of our usual battery of sanitation and quality and safety tests before resuming production.”
    Consumers who purchased any of the products listed 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.
    Retailer/Distributor
    Label Description/
    Brand
    Item Name
    Package&
    Weight
    Item SKU
    UPC Number
    Lot No.
    States Affected
    Best By
    Big Y Foods
    Green Giant Fresh
    Cauliflower Sweet Potato Crumbles
    1 lb.
    MXC100101
    605806000515
    190612-403102MA6/28/2019
    Green Giant Fresh
    Cauliflower Crumbles “Fried Rice” Blend
    1 lb.
    MXC101101
    605806000744
    190612-403101
    6/28/2019
    Green Giant Fresh
    Butternut Diced
    12 oz.
    BNC101101
    605806138010
    190614-403545
    6/26/2019
    Bozzutos
    Green Giant Fresh
    Cauliflower Sweet Potato Crumbles
    1 lb.
    MXC100101
    605806000515
    190612-403102
    CT
    6/28/2019
    Green Giant Fresh
    Cauliflower Crumbles “Fried Rice” Blend
    1 lb.
    MXC101101
    605806000744
    190612-403101
    6/28/2019
    C&S
    Green Giant Fresh
    Cauliflower Crumbles “Fried Rice” Blend
    1 lb.
    MXC101101
    605806000744
    190612-403101
    MA
    6/28/2019
    Green Giant Fresh
    Butternut Diced
    12 oz.
    BNC101101
    605806138010
    190614-403545
    6/26/2019
    Green Giant Fresh
    Butternut Cubed
    2 lb.
    BNC102101
    605806138218
    190614-403576
    6/26/2019
    Food Lion
    Green Giant Fresh
    Cauliflower Crumbles “Fried Rice” Blend
    1 lb.
    MXC101101
    605806000744
    190612-403101
    SC, NC, PA, VA
    6/28/2019
    Four Seasons
    Green Giant Fresh
    Ramen Bowl
    7.4 oz.
    MXC183104
    605806027864
    190614-403534
    PA
    6/28/2019
    Native Maine
    Growers Express
    Butternut Peeled
    10 lb.
    BNC103103
    Foodservice
    190614-403578
    PA
    Pack Date Only
    Procacci
    Green Giant Fresh
    Cauliflower Sweet Potato Crumbles
    1 lb.
    MXC100101
    605806000515
    190612-403102
    PA
    6/28/2019
    Ruby Robinson (PFG)
    Growers Express
    Butternut Peeled
    10 lb.
    BNC103102
    Foodservice
    190614-403577
    ME
    Pack Date Only
    Shaws
    Signature Farms
    Cauliflower Crumbles
    1 lb.
    CAC101109
    2113098438
    190612-403100
    MA
    6/28/2019
    Green Giant Fresh
    Cauliflower Sweet Potato Crumbles
    1 lb.
    MXC100101
    605806000515
    190612-403102
    6/28/2019
    Green Giant Fresh
    Ramen Bowl
    7.4 oz.
    MXC183104
    605806027864
    190614-403534
    6/28/2019
    Green Giant Fresh
    Butternut Diced
    12 oz.
    BNC101101
    605806138010
    190614-403545
    6/26/2019
    Stop & Shop
    Green Giant Fresh
    Zucchini Noodles
    10.5 oz.
    MSC104102
    605806000881
    190614-403567
    NY, MD
    6/26/2019
    Green Giant Fresh
    10.5 oz.
    190617-403954
    6/29/2019
    Trader Joe’s
    Trader Joe’s
    Butternut Squash Spirals
    10.5 oz.
    BCN105106
    623391
    190614-403565
    AL, CT, D.C., DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI,
    MN, MO, NC, NE, NH, NJ, NY, OH, PA, RI, SC, TN (only Knoxville, Nashville), VA, VT, WI
    6/28/2019
    Trader Joe’s
    Zucchini Spirals
    10.5 oz.
    MSC104106
    634908
    190617-403814
    AL, FL, GA, IA, IL, IN, KS, KY, MI, MN, MO, NC, NE, OH, SC, TN
    (only Knoxville, Nashville), VA (only Glen Allen, Newport News, Virginia Beach, Williamsburg), WI
    6/27/2019
    Customers also have been notified to remove any remaining products from shelves and inventory. Please refer to the toll-free number listed on each package with any questions or requests for refund. Visit http://www.GrowersExpress.com/voluntaryrecall
    External Link Disclaimer
    for the most up-to-date information.
    For over three decades, Growers Express has been committed to rigorous agricultural standards to ensure all vegetable products are the most wholesome and highest quality fresh vegetables available.

    About Growers Express
    Founded in 1987, Growers Express, LLC (GE) is an innovator of premium-quality fresh “value added” vegetable products, including first-to-market innovations such as Cauliflower Crumbles® chopped cauliflower, vegetable noodles and Veggie Bowls. Located in Salinas, California, also referred to as the “salad bowl of the world,” Growers Express is the primary licensed partner of Green Giant™ Fresh, the exclusive fresh produce arm of the iconic Green Giant® brand.

  • The FDA has become aware that an unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially connect wirelessly to a nearby MiniMed insulin pump with cybersecurity vulnerabilities. This person could change the pump’s settings to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis.Certain Medtronic MiniMed Insulin Pumps by Medtronic: Safety Communication – Due to Potential Cybersecurity RisksMedtronic cannot update the MiniMed™ 508 and Paradigm™ insulin pump models to address these potential cybersecurity risks. As a result, the FDA recommends patients replace affected pumps with models that are better equipped to protect them from these risks. To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks.
  • La Rosita Fresh Market Inc., a Mt. Prospect, Ill. retail store, is recalling approximately 54 pounds of raw ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The raw ground beef items are ground in the store and packaged for consumers behind the meat counter in varying weights. The raw ground beef items were packed on March 13, 2019 and March 14, 2019. The following products are subject to recall: [View Labels (PDF only)]
    Varying weights of ground beef packed in white trays with plastic wrap, containing “MOLIDA DE RES GROUND BEEF” with “Packed On 3/13/19 Sell By 3/20/19” or “Packed On 3/14/19 Sell By 3/21/19”.
    These items were only sold in the La Rosita Fresh Market Inc. retail store, located at 1805 W. Algonquin Rd., Mt. Prospect, IL, 60056. Consumers and members of the media with questions about the recall can contact Diane Perez, General Manager at La Rosita Fresh Market Inc., at (847) 305-0710.
  • Central Aquatics of Franklin, Wisconsin is recalling 96 cases of Aqueon Betta Food (item number 100106051 sold in a .95 oz jar) because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.Healthy people infected with Salmonella should monitor themselves for some or all the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.Fish with Salmonella infections are not well documented and fish carrying salmonella typically do not show any signs of disease.The Aqueon Betta Food, that is the subject of this recall, was distributed to Georgia, Illinois, New Jersey, and Pennsylvania via distribution centers.
  • Dublin, Ireland and Allegan, MI – Perrigo Company plc is issuing a voluntary nationwide recall of 35-ounce, 992-gram containers of Parent’s Choice Advantage Infant Formula Milk-Based Powder with Iron. This product, sold exclusively at Walmart, is being recalled because of the potential presence of metal foreign matter in a single lot of the product (C26EVFV). The total number of containers affected by this recall is 23,388.No adverse events have been reported to date, and the recall is being initiated out of an abundance of caution stemming from a consumer report. No other products or retailers are affected by this recall.Consumers who may have purchased the product should look for Lot Code C26EVFV with a “use by” date of February 26, 2021, which can be found on the bottom of the package. Any consumers who purchased the product should discontinue use and can visit any Walmart store for a refund.
  • BURLINGTON, MA and PLANO, TX – Keurig Dr Pepper today announced it will voluntarily withdraw Peñafiel unflavored mineral spring water products, imported from Mexico, due to the presence of violative levels of arsenic. Arsenic when present in the diet at very high levels, well above those detected in recent samples of Peñafiel, is associated with numerous chronic diseases. Water quality tests of Peñafiel samples conducted by an independent laboratory on behalf of Keurig Dr Pepper detected arsenic at levels that exceeded the FD!’s bottled water standards for mineral water of 10 ppb.
    All unflavored Peñafiel mineral spring water products including 600mL and 1.5L of all date codes are included in this voluntary withdrawal. The product is packaged in PET bottle formats. Consumers who have this product in their possession can return it to their retailer for a full refund.
    Peñafiel is a small brand in the U.S. and quantities in the marketplace are very limited, given that Keurig Dr Pepper has already begun to withdraw the products from the market. The Company has notified retailers that it will work with them to remove the product from the market.
    Arsenic is found in nature, including in aquifers that are the source of mineral water and where levels can vary over time. Keurig Dr Pepper has recently installed enhanced filtration systems at its facilities that produce Peñafiel, and the product now being produced is well within regulatory guidelines.
    No other Keurig Dr Pepper products are impacted by this voluntary removal. For further information, please contact the Keurig Dr Pepper Consumer Care hotline at (800) 696-5891 between the hours of 9:00 am and 8:00 pm EST, Monday through Friday. We are conducting this market action with the knowledge of the U.S. FDA.
    About Keurig Dr Pepper
    Keurig Dr Pepper (KDP) is a leading coffee and beverage company in North America, with annual revenue in excess of $11 billion. KDP holds leadership positions in soft drinks, specialty coffee and tea, water, juice and juice drinks and mixers, and markets the #1 single serve coffee brewing system in the U.S. The Company maintains an unrivaled distribution system that enables its portfolio of more than 125 owned, licensed and partner brands to be available nearly everywhere people shop and consume beverages. With a wide range of hot and cold beverages that meet virtually any consumer need, KDP key brands include Keurig®, Dr Pepper®, Green Mountain Coffee Roasters®, Canada Dry®, Snapple®, Bai®, Mott’s®, CORE® and The Original Donut Shop®. The Company employs more than 25,000 employees and operates more than 120 offices, manufacturing plants, warehouses and distribution centers across North America. For more information, visit http://www.keurigdrpepper.com
    External
  • San Giuseppe Salami Co. by Giacomo, an Elon, N.C., establishment, is recalling approximately 832 pounds of ready-to-eat (RTE), frozen andouille sausage products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The RTE, frozen andouille sausages were produced on May 14, 2019. The following products are subject to recall: [View Labels (PDF Only)]
    Varying weights of vacuum-packed, individually-sealed packages containing “SAN GIUSEPPE SALAMI CO. BY GIACOMO ANDOUILLE SAUSAGE (SMOKE FLAVORING ADDED)” with a “Sell By: 11/10/2019” date on the case labels.
    The products subject to recall bear establishment number “EST. 21556” inside the USDA mark of inspection. These items were shipped to retail and institutional locations in Greensboro, N.C.There have been no confirmed reports of adverse reactions due to consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. Consumers and members of the media with questions about the recall can contact San Giuseppe Salami Co. by Giacomo’s Plant Managers Francisco Grijalva or Giacomo Santomauro at (336) 586-7003. or at Francesco@sgsalami.com and Giacomo@sgsalami.com, respectively.
  • TOPIC: Multiple Losartan Potassium Products by Macleods Pharmaceutical Limited: Recall – Due to Detection of NMBA Impurity:

• Losartan Potassium 50mg (2 Lots)
• Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg (12 Lots)
• Losartan Potassium/Hydrochlorothiazide combination Tablets 100mg/12.5mg (3 Lots)
• Losartan Potassium/Hydrochlorothiazide combination Tablets 100mg/25mg (15 Lots)
AUDIENCE: Patient, Health Professional, Cardiology, Pharmacy

ISSUE: Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity was found in 32 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out. Please read the recall alert for a complete list of recalled products and lot numbers.

Healthcare 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.
Read Alert

  • Central Aquatics of Franklin, Wisconsin is recalling 96 cases of Aqueon Betta Food (item number 100106051 sold in a .95 oz jar) because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.Healthy people infected with Salmonella should monitor themselves for some or all the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.Fish with Salmonella infections are not well documented and fish carrying salmonella typically do not show any signs of disease.The Aqueon Betta Food, that is the subject of this recall, was distributed to Georgia, Illinois, New Jersey, and Pennsylvania via distribution centers.
  • MedWatch – The FDA Safety Information and Adverse Event Reporting ProgramTOPIC: Parent’s Choice Advantage Infant Formula Milk-Based Powder With Iron by Perrigo: Recall – Due to Potential Presence of Metal Foreign MaterialLot Code: C26EVFV with a “use by” date of February 26, 2021ISSUE: Perrigo Company is issuing a voluntary nationwide recall of 35-ounce, 992-gram containers of Parent’s Choice Advantage Infant Formula Milk-Based Powder with Iron.This product, sold exclusively at Walmart and is being recalled because of the potential presence of metal foreign matter in a single Lot #C26EVFV of the product. The total number of containers affected by this recall is 23,388.Healthcare 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.
    Read AlertU.S. Food and Drug Administration
    10903 New Hampshire Avenue, Silver Spring, MD 20993
    1-888-INFO-FDA (1-888-463-6332)
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  • Select Hudson RCI Sheridan Endotracheal Tubes by Teleflex Incorporated: Class I Recall – Due to the Potential for the Connector Disconnecting from the Endotracheal TubeThis voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT).1-800-332-1088 to request a reporting form,The immediate consequence for patients is disconnection from the breathing circuit, which may result in insufficient oxygenation, requiring medical intervention. There have been four reports of death, and additional reports of serious injury where ETT disconnection may have been a factor. For a complete list of products being recalled, please view the recall alert.Healthcare 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:
  • Teleflex Incorporated (NYSE: TFX), has announced a worldwide recall of certain lots of Hudson RCI@ Sheridan@ Endotracheal Tubes. The recalled products are designed for oral or nasal intubation and are indicated for airway management.These recalled products were distributed from October 2016 to May 2019. Specific lot codes may be found through the following link: https://p.widencdn.net/ivsxip/AN_ETT_Connector_Customer_Recall_Letter
    External Link DisclaimerThis voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). The immediate consequence for patients is disconnection from the breathing circuit, which may result in insufficient oxygenation, requiring medical intervention. There have been four reports of death, and additional reports of serious injury where ETT disconnection may have been a facto
  • Updates• 069-2019, Ruiz Foods Products Inc. Recalls Bacon Breakfast Wrap Products Due to Possible Foreign Matter Contamination (Jun 14, 2019)
    • 070-2019, C&S Wholesale Grocers Recalls Meat and Poultry Products due to Possible Temperature Abuse During Transport at Two Stores in New York (Jun 20, 2019)
  • Table 87 Frozen, LLC., a Brooklyn, N.Y. firm, is recalling an undetermined amount of frozen pizza products containing pork and beef that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The scope of this recall now includes ready-to-eat, prosciutto and pepperoni pizza products produced from June 3, 2017 through June 4, 2019. The following products are subject to recall: [View Labels (PDF only)]
    9.6-oz. plastic shrink-wrapped packages containing a single personal size pizza identified as “TABLE 87 COAL OVEN PIZZA Home Of The Coal Oven Slice PROSCIUTTO” with UPC codes 804879558286 and 10804879558283.
    9.7-oz. plastic shrink-wrapped packages containing a single personal size pizza identified as “TABLE 87 COAL OVEN PIZZA Home Of The Coal Oven Slice PEPPERONI” with UPC code 804879583080.
    On June 6, 2019, Table 87 Frozen, LLC. recalled approximately 649 pounds of frozen pizza products that contained pork produced from April 1, 2019 through June 4, 2019.
    9.6-oz. plastic shrink-wrapped packages containing a single personal size pizza identified as “TABLE 87 COAL OVEN PIZZA Home Of The Coal Oven Slice PROSCIUTTO” with UPC codes 804879558286 and 10804879558283.
    The products subject to recall bear establishment number “EST. 51192” inside the USDA mark of inspection. The firm applied this mark of inspection to the labels of the pork and beef pizza products without authorization. These items were shipped to retail and wholesale locations, as well as through online sales, nationwide. 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. Consumers and members of the media with questions about the recall can contact Robert Cucco, President, Table 87 Frozen, LLC., at (718) 287-8700.
  • C&S Wholesale Grocers, Inc. (“C&S”) is voluntarily recalling a number of perishable items sold at two Target stores. One store is located at 98 Veterans Memorial Highway in Commack, New York and the other is located at 160 North Research Place in Central Islip, New York. The products were not held at an appropriate temperature due to a mechanical malfunction during C&S transportation and may be unsuitable for human consumption. The recall includes items listed in the attached that were sold on June 17, 2019. No illnesses have been reported to date.
    This recall was initiated after C&S identified that the two Target stores received the shipment of the products. C&S is working collaboratively with USDA and FDA. Upon becoming aware of the situation, Target teams were directed to remove all of the impacted products from the Central Islip and Commack stores on the 17th. If consumers have purchased any of the affected products, they should dispose of the products and contact Target Guest Relations at 1-800-440-0680 for assistance and a full refund in the form of a Target gift card. Products purchased at any other Target store are not affected by this recall.
  • GE Healthcare has issued a Recall for all Giraffe Warmers and Panda iRes Warmers, used by hospitals and clinicians. This voluntary field corrective action is being initiated after GE Healthcare became aware that the bedside panels and latch areas on the beds may crack, break or become damaged if the unit is not properly used, by using the bedside panels to move the warmer instead of using the front handle or the rear maneuvering handle. http://s2027422842.t.en25.com/e/er?utm_campaign=Voluntary%20Field%20Corrective%20Action%20Issued%20for%20GE%20Healthcare%E2%80%99s%20Giraffe%20and%20Panda%20i-Res%20Infant%20Warmers&utm_medium=email&utm_source=Eloqua&s=2027422842&lid=8418&elqTrackId=10EA12797282EBC648EFFC8ABA819820&elq=a19d8bdc2cd047e5b27d3c98d1395763&elqaid=8428&elqat=1In March 2019, GE Healthcare notified all hospital customers of this issue through an Urgent Medical Device Correction notice and is now issuing a supplemental notice to all customers with additional clarificationsA MedWatch Safety Alert was just added to the FDA Recalls webpage.TOPIC: Infant Giraffe Warmers and Panda iRes Warmers by GE Healthcare: Recall – Bedside Panels and Latch Areas on the Beds May Crack, Break or Become Damaged if the Unit is Not Properly UsedAUDIENCE: Health Professional, Risk Manager, PediatricsISSUE: GE Healthcare issued a recall for all Giraffe Warmers and Panda iRes Warmers, used by hospitals and clinicians. This voluntary field corrective action is being initiated after GE Healthcare became aware that the bedside panels and latch areas on the beds may crack, break or become damaged if the unit is not properly used, by using the bedside panels to move the warmer instead of using the front handle or the rear maneuvering handle.Healthcare 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.
  • Premier Pharmacy Labs is voluntarily recalling all unexpired products, intended to be sterile, due to a lack of sterility assurance. The Unexpired Sterile Drug Product Lots (include dates dispensed) are being recalled due to concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination and lack of product specific process validations. The nationwide recall includes lots of sterile drug products to the consumer/user level.
    Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Premier Pharmacy Labs has not received any reports of adverse events related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.
    The scope of this recall is all commercially distributed product lots compounded in the Weeki Wachee, FL location currently within their labeled expiration date in response to an FDA concerns raised during the most recent inspection carried out from 29 April, 2019 to 12 June, 2019.
    Premier Pharmacy Labs is notifying customers of the voluntary recall by certified letter. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per the hospital protocol. Customers with any of the affected medications can also reference Premier Pharmacy Labs Website at https://premierpharmacylabs.com/
    External Link Disclaimer
    for more information on the specific lot numbers affected and contact information.
    Patients and healthcare providers with questions regarding this recall can contact Premier Pharmacy Labs at 1-800-752-7139, Monday through Friday, between 8:30am and 5pm, Central Standard Time or via e-mail at recalls@premierpharmacylabs.com.
    Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.
    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: http://www.fda.gov/medwatch/report.htm
    Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm 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
  • NATURE’S TOUCH FROZEN FOODS (WEST) INC. (“Nature’s Touch”) is voluntary recalling Signature Select Avocado Chunks, with a best before date of Oct 11, 20, due to potential contamination with Listeria monocytogenes (the “Product”).
    Nature’s Touch is issuing this voluntary recall based on strict precautionary measures after the company was informed by the FDA that a routine sampling program found a positive result for Listeria monocytogenes in one sample bag of 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.
    To date, there have been no reported illnesses associated with the product that is the subject of this precautionary recall:
    Brand
    Product
    Size
    UPC
    Codes
    Signature Select
    Avocado Chunks (Frozen)
    12 oz.
    2113009412
    UPC found on the back of the panel.
    Best Before
    OCT 11 20
    located at the back of the packaging
    The Product was distributed in the States of Alaska, Arizona, California, Colorado, Hawaii, Idaho, Nebraska, Nevada, New Mexico, Oregon, South Dakota, Washington, Wyoming, Texas and Utah and at these following banner stores:
    Albertsons
    Safeway
    Safeway Community Markets
    Carrs-Safeway
    Eagle
    Lucky
    Pak N Save
    Pavilions
    Vons
    Consumers who have purchased the Product should discard or return it to the place of purchase for a full refund.
    The Nature’s Touch Consumer Service Team will be available to answer any questions by phone at: 1-877-850-2664 between Monday to Friday 9:00 to 1700hrs EST or by email at: info@naturestouch.ca.
    At Nature’s Touch, our passion is finding the highest-quality frozen foods for our consumers and we are deeply committed to food safety at every production stage. This voluntary recall reflects our dedication to ensuring the safety of our consumers while enjoying our products.
  • Alert was just added to the FDA [ MedWatch, Recalls or Medical Devices] webpage.TOPIC: All Lots of All Sterile Products by Infusion Options: Recall – Due to Lack of Assurance of SterilityAUDIENCE: Patient, Health Professional, PharmacyISSUE: Infusion Options Inc. is voluntarily recalling all lots of all sterile products within expiry to the hospital level. These products are being recalled due to a lack of assurance of sterility. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Infusion Options Inc. has not received any reports of adverse events related to this recall. Healthcare 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.
  • Out of an abundance of caution, UNFI is voluntarily recalling its 10 ounce packages of Woodstock frozen Organic Grilled Red Peppers because they have the potential to be contaminated with 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 infections can cause miscarriages and stillbirths among pregnant women.
    The product comes in a 10 ounce plastic package marked with UPC code 4256301714, lot #60B, and an expiration date of April 2020 stamped on the back of the package and was distributed nationally to retail stores.
    No illnesses have been reported to date in connection with this problem.
    The potential for contamination was noted after routine testing by the Rhode Island Department of Health (RIDOH) revealed the presence of Listeria monocytogenes in the lot number identified above. The production of the product has been suspended while RIDOH and UNFI continue to investigate.
    Consumers who have purchased 10 ounce packages of Woodstock frozen Organic Grilled Red Peppers with the indicated lot code above, are urged to dispose of the product properly and may contact ResponseTeam@bluemarblebrands.com with any questions. Jeff Swanson
    952-903-1645
  • C&S Wholesale Grocers, located in Westfield, Mass. is recalling an undetermined amount of ready-to-eat and not-ready-to-eat meat and poultry products due to temperature abuse during transport, which may have resulted in the growth of spoilage organisms or pathogens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Temperature abuse may result in the growth of the proliferation of Staphylococcus aureus, Shiga-toxin producing E. coli, Listeria monocytogenes and Salmonella.
    The ready-to-eat and not-ready-to-eat meat and poultry products were sold on June 17, 2019, at two Target retail stores in New York. The Target stores are located at 98 Veterans Memorial Highway in Commack, New York and 160 North Research Place in Central Islip, New York.
    The complete list of products and UPC code numbers for products sold at the Commack, New York location can be found here.
    The complete list of products, product labels and UPC code numbers for products sold at the Central Islip, New York location can be found here.
    The labels for these products will be posted when available.Consumers may also contact Target Guest Relations at 1-800-440-0680 for assistance and a full refund in the form of a Target gift card. Products purchased at any other Target store are not affected by this recall.
  • Alma Pak of Alma, Georgia is recalling specific lots of product containing frozen blackberries (noted below) due to the potential of being contaminated with Norovirus. FDA testing of frozen blackberries was reported to have tested positive for Norovirus.
    Norovirus is a highly contagious virus. Consumption of product contaminated with Norovirus may cause acute onset of symptoms of gastroenteritis including severe nausea, vomiting and diarrhea. Less common symptoms are low-grade fever, chills, headache, muscle aches and fatigue. Although most symptoms end within 48 hours, the elderly, young children and immunocompromised persons may develop prolonged, or more severe symptoms.
    Specific lot information is as follows:
    Product
    UPC Code
    Retailer
    Lot Number
    Expiry Date
    Distributed to select stores in:
    Distribution Dates:
    16 oz Great Value Frozen Blackberries
    078742-431017
    Walmart
    AP1555
    AP1640
    AP1655
    1/25/2021
    3/07/2021
    4/08/2021
    AZ, FL, GA, NC, PR, SC, VA, WV
    1/31-2019 – 5/31/2019
    12 oz Tipton Grove Frozen Mixed Berries
    051933-34784-7
    Save-A-Lot
    AP 1700
    4/22/2021
    4/23/2021
    4/24/2021
    FL, NC, NY, TN, WI
    5/5/2019 – 5/15/2019
    No illnesses have been reported to date in connection with this recall. Impacted retailers have removed these products from store shelves. The FDA and the company continue to investigate the source of the issue.
    Consumers who have purchased the products are urged to destroy or urged to return them to the place of purchase for a full refund. Consumers with questions may contact Alma Pak at 1-866-965-3896, Monday – Friday, 8:00AM – 5:00PM EST.
  • In cooperation with ADM Milling Co., Brand Castle, LLC of Bedford Heights, Ohio is voluntarily recalling 25 oz and 32 oz glass jars of cookie and brownie mix out of an abundance of caution because it may be contaminated with pathogenic E. coli.
    The product is being recalled because an ingredient supplier, ADM Milling Co., has issued a recall for the flour used in these products due to E. coli contamination found in a single lot code of H&R Flour at their Buffalo production plant.
    E. coli symptoms include severe stomach cramps, diarrhea (often bloody) and vomiting. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.
    The products involved in this recall with UPC barcode and lot # are as follows:Brand Castle Arctic Chill Chocolate Mint Cookie Mix
    6-54448-01035-2
    L6112618
    As potential retail product in OHIO as product samples only
    Brand Castle Hot Cocoa Cookie Mix
    6-54448-01036-9
    L5111918
    To retail stores in Alabama, New York, South Carolina
    Sisters Gourmet Million Dollar Cookie Mix
    6-54448-00002-5
    L2121818
    To retail stores in Minnesota, Missouri, New York
    Sisters Gourmet Billion Dollar Brownie Mix
    6-54448-00017-9
    31OCT2019BC8324
    To retail stores in Missouri, Utah
    In the Mix Chocolate Mint Chip Cookie Mix
    6-54448-01081-9
    LM101518
    To retail stores in Iowa, Missouri, Kansas, Nebraska
    Brand Castle The Grinch Sugar Cookie Mix with Sprinkles
    6-54448-01038-3
    25JUL2019BC8324
    To Ohio
    To date, no illnesses have been reported with these products and no further product have been shipped from our facility.
    Consumers who have purchased this product should return it to the retailer for a full refund, discard the product, or reach out to Brand Castle, LLC with proof of purchase for a full refund.
    Consumers who have questions should contact Brand Castle, LLC at 216-292-7700 ext. 331 Monday through Friday between the hours of 7:30 am and 4:30 pm EST or email at jonn.cotter@brandcastle.com.
  • C&S Wholesale Grocers, Inc. (“C&S”) is voluntarily recalling a number of perishable items sold at two Target stores. One store is located at 98 Veterans Memorial Highway in Commack, New York and the other is located at 160 North Research Place in Central Islip, New York. The products were not held at an appropriate temperature due to a mechanical malfunction during C&S transportation and may be unsuitable for human consumption. The recall includes items listed in the attached that were sold on June 17, 2019. No illnesses have been reported to date.
    This recall was initiated after C&S identified that the two Target stores received the shipment of the products. C&S is working collaboratively with USDA and FDA. Upon becoming aware of the situation, Target teams were directed to remove all of the impacted products from the Central Islip and Commack stores on the 17th. If consumers have purchased any of the affected products, they should dispose of the products and contact Target Guest Relations at 1-800-440-0680 for assistance and a full refund in the form of a Target gift card. Products purchased at any other Target store are not affected by this recall. http://wcms-internet.fda.gov/files/recalls/unpublished/T1108%20Commack%20NY%20Product%20List-Descriptions-FDA.pdf http://wcms-internet.fda.gov/files/recalls/unpublished/T2102%20Commack%20NY%20Product%20List-Descriptions-FDA.pdf
  • Sprouts Farmers Market of Phoenix, AZ is recalling Frozen Cut Leaf Spinach conventional and organic 16oz bags, manufactured by National Frozen Foods of Oregon, 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.
    Sprouts Recalls the following product:
    Sprouts Frozen Cut Leaf Spinach, 16oz. bag, UPC 87487500982, Lot 19031203A03, USE BY 12/03/21. Identifying information can be found on the back of the package.
    Sprouts Frozen Organic Cut Leaf Spinach, 16oz. bag, UPC 87487500991, Lot 19031203A03, USE BY 12/03/21. Identifying information can be found on the back of the package
    Product was distributed to retail locations in AZ, CA, NV, UT, NM, CO, TX, KS, OK, MO, TN, AL, GA, FL, SC, NC, PA, MD, and VA.
    No illnesses have been reported in connection to this product to date.
    The recall is due to random sampling which revealed the finished products contained the bacteria. Sprouts Farmers Market has removed all affected product from its retail stores. In addition, Sprouts is conducting an internal investigation with National Frozen Foods to ensure all food safety standards and being met and enforced.
    Consumers who have purchased the products are urged to destroy or return it to the stores for a full refund of the product. Consumers with questions may contact the company at 1 (888) 577-7688 from 8am to 5pm PST
  • A nationwide voluntary recall was issued for certain Ragu pasta sauces and El Monterey Breakfast Wraps. CBS Radio
    According to the Ragu, certain sauces are being recalled that may contain pieces of plastic.
    *The voluntary recall includes Ragu’s Chunky Tomato Garlic & Onion (45-ounce and 66-ounce jars), Old World Style Traditional (66-ounce jars) and Old World Style Meat (66-ounce jars) with sell-by dates of June 5.
    Nearly 250,000 pounds of El Monterey Breakfast Wraps have also been recalled for possibly containing rocks and other materials.
    *El Monterey’s recall includes the family size 8-pack of the Egg, Potato, Bacon, & Cheese Sauce Breakfast Wraps produced in January.
    The USDA has received at least three consumer complaints.
    Consumers are requested to check their pantries and freezers and discard any products that may have been recalled.
  • Shivam Distributors of Longwood, FL is recalling its 14 ounce packages of “Dry Dates” because they contain high sulfite content a preservative which could cause adverse health consequences with symptoms such as itchiness, upset stomach, headache, stiffness, diarrhea, cough, nausea and weakness.
    The recalled “Dry Dates” were distributed in Florida (Tampa, Orlando, Jacksonville, Panama City, Tallahassee, Pembroke Pines, Lake Mary, and Deland) and in Savannah Georgia, Charleston South Carolina, Winston Salem North Carolina, through retail stores from June 2018 to May 2019.
    The product comes packed in a 14 ounce, printed plastic bag packing marked Parivar brand with batch # 127/BHBI and UPC # 879111001226 on the back of the bag.
    No illnesses have been reported to date in connection with this problem.
    The recall was the result of a random testing done on May 21 2019 by FL agriculture department which notified our company on June 5, 2019 that revealed high sulfite level in the 14 ounce packages of “Dry Dates” with batch # 127/BHBI.
    The distribution of the product has been ceased.
    Customers who have purchased 14 ounce packages of “Dry Dates” with batch # 127/BHBI are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-407-331-9439 Monday to Friday 9AM to 5PM EST.
  • Hometown Food Company, in cooperation with ADM Milling Co., today initiated a voluntary recall of two specific lot codes of its Pillsbury® Best 5 lb. Bread Flour due to a potential presence of pathogenic E. coli. The product was manufactured by ADM Milling Co., at the company’s mill in Buffalo, NY.
    The severity of E. coli infections vary among people and often include several symptoms, including severe stomach cramps, diarrhea (often bloody) and vomiting. People usually develop symptoms and get sick 3-4 days after ingesting the germ, and most recover within a week. In some cases, individuals may develop a serious illness called hemolytic uremic syndrome (HUS, which can result in kidney failure, stroke, and even death). Young children, elderly individuals, pregnant women and those who are immunocompromised are more susceptible to foodborne illness. If you feel ill or are at all concerned about an illness, please contact your physician.
    Approximately 4,620 cases of impacted Pillsbury® Best 5 lb. Bread Flour were distributed to a limited number of retailers and distributors across the following 10 states: Connecticut, Delaware, Maryland, Maine, New Hampshire, New Jersey, New York, Ohio, Pennsylvania and Virginia.
    The affected product has the following UPC codes, lot codes and Best-If-Used-By dates:Item Name
    UPC Item Code
    Lot
    Code
    Use-By Date
    QTY (Eight-Count Case)
    Pillsbury Best™ Bread
    Flour
    0 5150020031 5
    8 342
    JUN 08 2020
    4,080
    Pillsbury Best™ Bread
    Flour
    0 5150020031 5
    8 343
    JUN 09 2020
    540
    All products with other Best-If-Used-By Dates and Lot Codes are not affected by this recall. Best-If-Used By Dates can be found on the side of the package below the Nutrition Facts Panel.
    If you have the affected product in your home or business, do not consume it. Please discard it immediately or return it to the retail location it was purchased from for a refund. This voluntary recall is being made with the full knowledge of the U.S. Food and Drug Administration.
    At Hometown Food Company, nothing is more important than the safety and integrity of our products.
    There have been no reports of any illnesses associated with this product and this recall has been issued out of an abundance of caution. Hometown Food Company has been informed by ADM Milling Co., that certain wheat used to make these two lots of Pillsbury® Best 5 lb. Bread Flour has been linked to E. coli illnesses associated with other flour products produced at the ADM mill in Buffalo. Please visit the U.S. Food and Drug Administration’s website for more information on this illness outbreak. To date, no illnesses associated with Pillsbury® Best Bread Flour have been reported.
    Flour is made from wheat, which is a raw product that is minimally processed. Flour is not a ready-to-eat product. It is an ingredient for baked, fried and cooked recipes, and these heating processes, along with proper handling, ensure the safety of consuming flour. All surfaces and utensils should be properly cleaned after contact with flour or uncooked dough or batter. Consumers should wash their hands after handling flour or uncooked dough or batter. Consumers should not eat uncooked dough or batter made with raw flour.
    We sincerely apologize for any inconvenience this recall may cause, and are offering replacement coupons for your product. Please call our toll-free 800 number (1-866-219-9333), which will be staffed daily from 9:00 a.m. to 9:00 p.m. CDT. We remain committed to producing the high-quality products synonymous with the Pillsbury® name since 1869.
  • WinCo Foods, LLC. Of Boise, ID is recalling Frozen Red Raspberries, 12 ounce bag, manufactured by Rader Farms of Bellingham, WA, because it has 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 potentially affected product from store shelves.
    Product was distributed to WinCo Foods stores in Arizona, California, Idaho, Montana, Nevada, Oklahoma, Oregon, Washington, Texas, and Utah.
    WinCo recalls the following product:
    WINCO FOODS FROZEN RED RASPBERRIES, 12 oz bag, UPC 0 70552 30501 4.
    Best By Code Feb/13/2021 with lot number 4045902. The best code is found on the back side of a bag next to the UPC bar code.
    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 it to the stores for a full refund of the product. Consumers with questions may contact the company at 1-800-824-1706, Mon-Fri, 7:30-4:30 MST.
  • Ruiz Foods Products Inc., a Denison, Texas, establishment, is recalling approximately 246,514 pounds of frozen, not ready-to-eat (NRTE) breakfast wrap products containing bacon that may be contaminated with extraneous materials, specifically small rocks, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen egg, potato, bacon and cheese wrap items were produced on Jan. 17, 2019 and Jan. 18, 2019. The following product is subject to recall: [View Labels (PDF only)]
    8-Pack family size film packages containing “EL MONTEREY EGG, POTATO, BACON & CHEESE SAUCE BREAKFAST WRAPS” with “Best if Used By” dates of 01/17/2020 and 01/18/2020 and lot codes 19017 and 19018.
    The products subject to recall bear establishment number “EST. 17523A” on the back of the package. These items were shipped to retail locations nationwide.
    Members of the media with questions about the recall can contact Pat Summers, Public Relations Consultant for Ruiz Foods, at 559-285-1100. Consumers with questions about the recall can contact Ruiz Foods’ Consumer Line at 1-800-772-6474.
    The problem was discovered on June 14, 2019, when Ruiz Foods advised FSIS of three consumer complaints regarding foreign material in the wrap products. The firm continues to investigate the source of the foreign material.
  •  MedWatch – The FDA Safety Information and Adverse Event Reporting ProgramTOPIC: Losartan Potassium to 50 mg and 100 mg Tablets USP by Teva Pharmaceuticals USA: Expanded Recall – Due to the Detection of an Impurity – N-Nitroso-N-methyl-4-aminobutyric acidAUDIENCE: Patient, Health Professional, Cardiology, PharmacyISSUE: Teva Pharmaceuticals USA, Inc. has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the United States of losartan potassium tablets. This expanded recall includes 6 lots of bulk losartan potassium USP Tablets due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the FDA’s interim acceptable exposure limit of 9.82 ppm.The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Limited, which was used in the manufacturing of the 6 bulk lots of these drug products.The affected losartan potassium tablets being recalled are described as:• Two lots of 50 mg strength losartan potassium tablets USP 50 mg. The tablets are green, film-coated, oval-shaped biconvex tablets with “LK 50” on one side and “>” on the other side.
    Four lots losartan potassium tablets, USP 100 mg. The tablets are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and “>” on the other side.
    Read RecallU.S. Food and Drug Administration
    10903 New Hampshire Avenue, Silver Spring, MD 20993
    1-888-INFO-FDA (1-888-463-6332)
    Privacy Policy | http://www.fda.gov
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  • Out of an abundance of caution, Townsend Farms, Inc. has notified Costco that a recent FDA test indicated that a domestic conventional frozen blackberry product manufactured by Townsend Farms, Inc., may be contaminated with Hepatitis A. Townsend Farms, Inc. used the domestic conventional frozen blackberry to manufacture the Kirkland Signature Three Berry Blend product with Best By Dates between February 16, 2020, and May 4, 2020. Costco only sold the product in stores located in San Diego and Los Angles, California and Hawaii. No product manufactured for Costco by Townsend Farms has tested positive for Hepatitis A. Costco has no product in its current inventory. Costco has been notifying its members about the potential health risk.
    This Notice affects the following product:
    KIRKLAND SIGNATURE THREE BERRY BLEND, 4 lb bag —
    Best By codes located in the white box on the back of the Product bag:
    FEB1620,(A),(B),(C),(D),(E),(F),(G), or (H);
    FEB1820,(A),(B),(C),or (D);
    FEB2920,(A),(B),(C),or (D);
    MAR0120,(A),(B),(C),or (D);
    APR1920,(B),(C), or (D);
    APR2020(A),(B),(C),(D),(E), or (F);
    APR2720(A),(B),(C),(D),(E),(F),(G), or (H);
    APR2820(A),(B),(C),(D),(E),(F),(G), or (H);
    MAY0220(A),(B),(C),(D),(E),(F),(G), or (H);
    MAY0420 (H).
    According to the FDA and CDC there have been no customer illness reports to date related to any product manufactured by Townsend Farms, Inc., using these blackberries.
    Members who have purchased the above product should not consume it. Instead, photograph the product bag for your records, dispose of the product and contact your local Costco for a full refund.
    Costco members who have questions should contact Townsend Farms, Inc., customer service representatives at 877-244- 0947 or by email at TownsendFarms4283@stericycle.com.
    Hepatitis A is a contagious liver disease that results from exposure to the Hepatitis A virus, including from food. It can range from a mild illness lasting a few weeks to a serious illness lasting several months. Illness generally occurs within 15 to 50 days of exposure and includes fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine and pale stool. Hepatitis A vaccination can prevent illness if given within two weeks of exposure to a contaminated food. In rare cases, particularly consumers who have a pre-existing severe illness or are immune compromised, Hepatitis A infection can progress to liver failure. Persons who may have consumed affected product should consult with their health care professional or local health department to determine if a vaccination is appropriate, and consumers with symptoms of Hepatitis A should contact their health care professionals or the local health department immediately.
    Townsend Farms, Inc., is a family owned business that has been farming in Oregon since 1906. We are dedicated to safety in our food processing and sustainable farming practices. We utilize Good Agricultural Practices as well as Good Manufacturing Practices and are Safety Quality Food certified. We take your food safety seriously.
    FDA Web Post
    Updated Press Release
  • In cooperation with ADM Milling Company, King Arthur Flour, Inc. of Norwich, VT is voluntarily recalling 14,218 cases of 5 lb. Unbleached All-Purpose Flour due to the potential presence of Escherichia coli bacteria (E. coli).
    The recalled Unbleached All-Purpose Flour (5 lb.) was distributed through retailers and distributors nationwide. No products sold through our website, Baker’s Catalogue, or the Baker’s Store in Norwich, VT are included in this voluntary recall.
    The only product affected by this voluntary recall is our Unbleached All-Purpose Flour (5 lb.) from these six specific lot codes and three Best Used by Dates, which can be found on the bottom of the side panel, below the nutrition facts panel.BEST USED BY 12/07/19 LOT: L18A07C
    BEST USED BY 12/08/19 LOTS: L18A08A, L18A08B
    BEST USED BY 12/14/19 LOTS: L18A14A, L18A14B, L18A14C
    E. coli causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.
    King Arthur has been informed by ADM Milling Co. that certain wheat used to make these lots of King Arthur flour has been linked to an ongoing outbreak of E. coli infections. No illnesses have been reported to date in connection with King Arthur flour.
    Consumers who have any of these affected products should not consume them and should throw them away or return them to the place of purchase for credit or refund.
    Consumer safety is our top priority, and therefore, we are voluntarily recalling these specific lots of Unbleached All-Purpose Flour to prevent potential illnesses. We are committed to educating and reminding consumers that flour is not ready-to-eat, and anything made with flour must be baked before eating,
    Consumers are reminded to wash their hands, work surfaces, and utensils thoroughly after contact with raw dough products or flour, and to never eat raw dough or batter. For more information about risks of consuming raw dough, refer to the following: https://www.cdc.gov/features/no-raw-dough/index.html.
    Customers have trusted King Arthur Flour products in their kitchens for over 225 years and that’s why we have issued this voluntary recall. We remain committed to providing our customers safe and superior products.
    This information can be found online at kingarthurflour.com/voluntaryrecall
    External Link Disclaimer
    .
    External Link Disclaimer
    Customers with any questions regarding this recall or King Arthur Flour products are encouraged to call the King Arthur Flour Consumer Hotline 7 days a week/24 hours a day at 866.797.9178
  • Pasture Raised Foods, LLC, doing business as Greener Pastures Chicken, a grower/non-inspected processor located in Elgin, Texas, is recalling an undetermined amount of frozen raw whole poultry products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen raw whole poultry items were produced from Nov. 29, 2018 through May 24, 2019. The following products are subject to recall: [View Labels (PDF only)]
    Varying weight vacuum sealed packages containing one whole “GREENER PASTURES CHICKEN” with the head and feet removed.
    The products do not bear an official USDA mark of inspection but were labeled with establishment number “USDA P-34438” on the product label without authorization. These items were shipped to retail, wholesale, and restaurant locations, and to individual households in Texas.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. Consumers and members of the media with questions about the recall can contact Cameron Molberg, Co-CEO of Pasture Raised Foods, LLC, at (202) 642-5417
  • The Kroger Co. (NYSE: KR) said today it is recalling Private Selection Frozen Triple Berry Medley (48 oz), Private Selection Frozen Triple Berry Medley (16 oz), and Private Selection Frozen Blackberries (16 oz) manufactured by Townsend Farms due to possible Hepatitis A contamination.
    No customer illnesses have been reported to date. Kroger was informed by the FDA that a sample of the Private Selection frozen berries was tested by the FDA and found to be contaminated with Hepatitis A.
    Kroger is recalling the following items, which were distributed to all Kroger family of store banners
    External Link Disclaimer
    across the country:
    PRIVATE SELECTION FROZEN TRIPLE BERRY MEDLEY, 48 OZ (BEST BY: 07-07-20; UPC: 0001111079120);
    PRIVATE SELECTION FROZEN TRIPLE BERRY MEDLEY, 16 OZ (BEST BY: 06-19-20; UPC: 0001111087808);
    PRIVATE SELECTION FROZEN BLACKBERRIES, 16 OZ (BEST BY: 06-19-20, 07-02-20; UPC: 0001111087809)
    Kroger has removed the potentially affected items from store shelves and initiated its customer recall notification system that alerts customers who may have purchased recalled products through register receipt tape messages and phone calls.
    Customers who have purchased the above products should not consume them and should return them to a store for a full refund or replacement.
    Customers who have questions may contact Kroger at 1-800-KROGERS Monday through Friday, 8:00 AM to midnight EST, and Saturday and Sunday, 8:00 AM to 9:30 PM EST.
    Hepatitis A is a contagious liver disease that results from exposure to the Hepatitis A virus, including from food. It can range from a mild illness lasting a few weeks to a serious illness lasting several months. Illness generally occurs within 15 to 50 days of exposure and includes fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine and pale stool. Hepatitis A vaccination can prevent illness if given within two weeks of exposure to a contaminated food. In rare cases, particularly consumers who have a pre-existing severe illness or are immune compromised, Hepatitis A infection can progress to liver failure. Persons who may have consumed affected product should consult with their health care professional or local health department to determine if a vaccination is appropriate, and consumers with symptoms of Hepatitis A should contact their health care professionals or the local health department immediately.
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  • Taylor Farms Illinois, Inc., a Chicago, Ill. establishment, is recalling approximately 51 pounds of cheese and bacon quiche products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains eggs, a known allergen, which is not declared on the product label.
    The Jarlsberg cheese and bacon quiche items were produced on June 5, 2019. The following products are subject to recall: [View Labels (PDF only)]
    10-oz. individual plastic containers containing “JARLSBERG & BACON QUICHE” with lot code TFIL156A001 and “USE BY: 06/11/19.”
    The products subject to recall bear establishment number “EST. 21794” inside the USDA mark of inspection. These items were shipped to retail locations in Arkansas, Georgia, Kentucky, Mississippi, Ohio, Tennessee, and West Virginia.
    The problem was discovered on June 8, 2019 when Taylor Farms Illinois, Inc. notified FSIS that the incorrect bottom package label had been applied to the product.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. Consumers with questions about the recall can contact the Taylor Farms Hotline at (855) 455-0098. Members of the media with questions about the recall can contact press@taylorfarms.com.
  • Tyson Foods, Inc., a New Holland, Pa. establishment, is recalling approximately 190,757 pounds of ready-to-eat chicken fritter products that may be contaminated with extraneous materials, specifically hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen ready-to-eat chicken fritter items were produced on February 28, 2019. The following products are subject to recall:
    32.81-lb. cases containing four 8.2-lb. bags of “FULLY COOKED, WHOLE GRAIN GOLDEN CRISPY CHICKEN CHUNK FRITTERS-CN” and case code 0599NHL02.
    The products subject to recall bear establishment number “P-1325” inside the USDA mark of inspection. The recalled items were shipped to institutional foodservice locations nationwide and were not packaged for retail sale.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.
    Consumers with questions about the recall can contact Tyson Foods Consumer Relations at (888) 747-7611. Members of the media with questions about the recall can contact Worth Sparkman, Public Relations and Corporate Affairs, at (479) 290-6358.
  • Table 87 Frozen, LLC., a Brooklyn, N.Y. firm, is recalling approximately 649 pounds of frozen pizza products that contain pork that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen prosciutto pizza products were produced from April 1, 2019 through June 4, 2019. The following products are subject to recall: [View Labels (PDF only)]
    9.6-oz. plastic shrink-wrapped packages containing a single personal size pizza identified as “TABLE 87 COAL OVEN PIZZA Home Of The Coal Oven Slice PROSCIUTTO” with UPC code 804879558286 and 10804879558283.The products subject to recall bear establishment number “EST. 51192” inside the USDA mark of inspection. These items were shipped to retail and wholesale locations, as well as through online sales, nationwide.Consumers and members of the media with questions about the recall can contact Robert Cucco, President, Table 87 Frozen, LLC., at (718) 287-8700.
  • Los Hernandez, LLC., a Moxee, Wash. establishment, is recalling approximately 9,090 pounds of chicken and pork tamales that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The tamale products were produced from Dec. 3, 2018 through Feb. 7, 2019. The following products are subject to recall: [View labels (PDF only)]
    30-lb. boxes of “Los Hernandez Authentic Pork TAMALES Hand Made”.
    30-lb. boxes of “Los Hernandez Authentic Chicken TAMALES Hand Made”.
    These items were shipped to a Los Hernandez Tamales Restaurant in Union Gap, Washington, owned by the recalling establishment. The individual tamales may have been packaged and sold to consumers from December 2018 through May 1, 2019. There are no specific identifying labels for consumers who may have carried out the tamales from the restaurant.
    The problem was discovered during routine FSIS verification activities.
    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.Consumers and members of the media with questions about the recall can contact Felipe Hernandez, President, Los Hernandez Tamales, LLC, at (509) 571-1394.
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