Daily Archives: 05/06/2023
USDA May 2023 Recall – Safety Alerts Previous Month & last day of prior month updates
** Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support
- Product Names: Seattle PAP Plus, VentStar Basic (P)180, VentStar Basic(P)250, VentStar Watertrap (P) 180, VentStar Watertrap (P) 180 w/oLL, VentStar Anesthesia WT (P)180, VentStar breathing bag Set (P) 110, ID Circuit Basic (P) 180, VentStar Anesthesia (N) 180, VentStar Basic (N) 180, VentStar Watertrap (N), 180 VentStar Bag Set (N) 110, VentStar Coax (P) 150, Anesthesia Circuit Kit Coax 1, Anesthesia Circuit Kit Coax 3, Ventstar Coax, Ventstar Coax 180, ID Coax 180, Ventstar Coax 230, Anesthesia Set Coax 180, Set2Go Ventilation 12 (A), and Anesthesia Circuit Kit Coax HEPA
- Product Material Numbers: See Recall Database Entry
- Distribution Dates: January 1, 2019 to February 28, 2023
- Devices Recalled in the U.S.: 570,459
- Date Initiated by Firm: April 17, 2023
** Associated Wholesale Grocers, Inc. is Releasing this Notice Due to Recalled Infant Formula Being Distributed to its Nashville Division Retailers after the Initial Recall Notice was Published
On March 17, 2023, the Perrigo Company issued a voluntary recall of certain lots of Gerber® Good Start® SootheProTM Powdered Infant Formula in the U.S., that were manufactured at the Company’s Gateway Eau Claire, Wisconsin manufacturing facility from January 02, 2023 to January 18, 2023. This product was recalled out of an abundance of caution due to the potential presence of Cronobacter sakazakii. Associated Wholesale Grocers, Inc. (AWG) is releasing this additional notice due to one of the recalled products being distributed to its Nashville Division retailers after the initial recall notice was published.Cronobacter sakazakii is a bacteria commonly found in the environment. In most people, it causes no symptoms but in some, particularly premature infants, infants under 2 months of age or infants with weakened immune systems, fever, poor feeding, excessive crying or low energy as well as other serious symptoms can occur.
** Cricket Creek Farm Recalls Sophelise and Tobasi Cheeses Because of Potential Listeria Monocytogenes Contamination
Cricket Creek Farm of Williamstown, MA is recalling 165 units of Sophelise cheese and 149 pounds of Tobasi 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.
Sophelise and Tobasi were distributed in Massachusetts and New York through Wild Oats, Williamstown, MA; Provisions Williamstown, Williamstown, MA; McEnroe Organic Farm Market, Millerton, NY; New Lebanon Farmers Market; New Lebanon, NY, at restaurants, and farmers markets. Sophelise product code: 087055 is a washed, pasteurized milk cheese with a soft rind and pinkish hue; the circular cheese measures 4 inches in diameter and roughly 1 inch tall. It is sold in semi-transparent packaging with a round blue label. Sophelise was distributed between March 29, 2023 and May 26, 2023.
** Salmonella outbreak in 6 states linked to Papa Murphy’s cookie dough: CDC
Papa Murphy’s raw cookie dough:
- Chocolate chip cookie dough
- S’mores bars dough
- The dough is not meant to be eaten raw.
Nine sick people reported eating raw cookie dough from Papa Murphy’s Take ‘N’ Bake Pizza in the week before they got sick. Based on this information, Papa Murphy’s has temporarily stopped selling their raw chocolate chip cookie dough and raw S’mores bars dough.
At least two sick people did not eat at Papa Murphy’s. Investigators are working to identify the contaminated ingredient in the raw cookie dough.
** Novis PR LLC Emite Retiro Voluntario de Gotas Pediátricas G-Supress DX Debido a Empaque Incorrecto
15/05/23– San Juan, PR, Novis PR LLC está retirando voluntariamente el lote D20911 Exp 10/25 de gotas pediátricas G-Supress DX a nivel de consumidor. Se ha encontrado que algunas cajas del producto contienen un producto incorrecto en su interior. El producto incorrecto en el interior es un anestésico/analgésico y no una marca de Novis PR LLC. El producto anestésico/analgésico contiene 60% de alcohol etílico y 5% de benzocaína. Existe la probabilidad de eventos adversos graves con un producto que contiene alcohol, incluida la toxicidad por alcohol. Los bebés y los niños pequeños son propensos al coma por hipoglucemia profunda ya la hipotermia por la ingestión de cantidades relativamente pequeñas de etanol, y se han informado muertes. Además, el producto contiene benzocaína, pero no incluye una advertencia de metahemoglobinemia, que es una condición en la que se entrega muy poco oxígeno a las células que puede poner en peligro la vida. Hasta la fecha, Novis PR LLC no ha recibido ningún informe de eventos adversos o lesiones relacionadas con este retiro.
** TOPIC: G-Supress DX Pediatric Drops by Novis PR: Recall – Due to Incorrect Packaging
AUDIENCE: Consumer, Patient, Health Professional, Pharmacy, Pediatrics, Family Practice
ISSUE: Novis PR is recalling Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops because some cartons of the product have been found to contain incorrect product inside. Incorrect product inside is an anesthetic/analgesic and not a brand of Novis PR.
Anesthetic/Analgesic product contains 60% ethyl alcohol and 5% benzocaine. There is a probability of serious adverse events with a product containing alcohol including alcohol toxicity. Infants and young children are prone to profound hypoglycemia coma, and hypothermia from ingesting relatively small amounts of ethanol, and deaths have been reported. Furthermore, the product contains benzocaine but does not include a warning for methemoglobinemia which is a condition in which too little oxygen is delivered to your cells that can be life-threatening. Lot D20911 was distributed among pharmacies in Puerto Rico. 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.
To date, Novis PR has not received any reports of adverse events or injuries related to this recall.
** Updates: 015-2023, Alef Sausage Inc. Recalls Ready-To-Eat Meat and Poultry Sausage Products Due to Misbranding and Possible Temperature Abuse (Apr 21, 2023)
- 012-2023, Weinstein Wholesale Meats, Inc. Recalls Raw Ground Beef Burger Products Due to Possible Foreign Matter Contamination (Apr 20, 2023)
** Chang Farm Expands Recalls Mung and Soy Bean Sprouts Because of Possible Health Risk
Chang Farm, 301 River Road, Whatley, MA is expanding their recall to include ALL Mung Bean Sprouts and Soy Bean Sprouts within expiry because of the possible presence of Listeria monocytogenes (L. 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 headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
The affected product is packaged in
- Beans Sprouts 10lb bag and bag in box
- Nature’s Wonder Premium Beans Sprouts 12oz bag (UPC: 815098001330)
Nature’s Wonder Premium Soybean Sprouts 12oz bag (UPC: 815098001347)
** CORRECTION NOTICE: New Hampshire Laboratory Error Incorrectly Resulted in Recall of lēf Farms “Spice” Packaged Salad Greens: Recall Canceled
Concord, NH – The New Hampshire Department of Health and Human Services (DHHS) has determined that a laboratory error incorrectly caused last week’s recall announcement concerning lēf Farms “Spice” Packaged Salad Greens. The products from lēf Farms are safe and the recall has been canceled.
** lēf Farms Recalls “Spice” Packaged Salad Greens Because of Possible Health Risk
lēf Farms of Loudon, N.H. is voluntarily recalling a single lot of the lēf Farms “Spice” Packaged Salad Greens (“best by” date 5/5/23, lot number SP10723- 1RGH1, UPC 8 50439 00709 1) produced in its Loudon, New Hampshire greenhouse because they have the potential to be contaminated with Escherichia coli 0157:H7 (E. coli) bacteria. According to the Food and Drug Administration (FDA), 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. The product comes in a 4- oz, clear, plastic clamshell container. Information about the “best by” date, lot number and UPC can be found at the bottom of the package. Pictures to assist customers in identifying the recalled products are found at the end of this announcement.
** Lancaster Foods Updates Voluntary Recall of Various Expired Kale, Spinach and Collard Green Products Due to Potential Health Risk
Lancaster Foods has updated their May 5, 2023 Recall notice to add one product (Lancaster Brand Spinach item #41714, “Best If Used By” date April 29, 2023).
Lancaster Foods is voluntarily recalling a limited quantity of 3 brands of already-expired Robinson Fresh, Lancaster, and Giant brand Kale, Spinach and Collard Green products produced at the company’s Jessup, Maryland facility. This recall is due to a possible health risk from Listeria monocytogenes. No related illnesses have been reported to date. The recalled products are beyond their “Best If Used By Date”.Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.
** Hauppauge, NY, May 10, 2023– BearCare, Inc. is initiating a voluntary recall of its rechargeable Walnut Wearable Smart Thermometer (Walnut Thermometer) due to reports of injuries, including skin burns, by users. The Walnut Thermometer is an over-the-counter rechargeable device intended for continuous chest temperature monitoring of children ages 0-6 years which can be identified by its silicone exterior resembling a cartoon penguin. The product under recall was sold and distributed from December 2022 to April 2023 through Amazon.com, Walmart.com, and http://www.walnutcares.com.
Components shown above: (1) thermometer unit; (2) base station; (3) adhesive strip; (4) user manual; (5) charging cable.
|Product Name||Distribution Dates||Lot Number||Model Number|
|December 2022 and later||20221115W002||WT20|
How to recognize the device may fail: users may identify a failing device if the user observes any substance leaking from the device’s exterior, any corrosion near the smart sensor on the back of the device, diminished battery life, or connectivity issues with the Walnut App. In addition, a sensation of warming or heat at or near the site or redness and irritation on the skin are also signs of that a device is failing.
Actions to take: Consumer are advised to immediately stop using the product. Caution should be taken if there is evidence of moisture or leakage since this may pose a risk of chemical burns to users as well as caretakers or others handling the product. Given the vulnerable population of neonates and infants, other areas of the body should be checked, including the mouth and eyes due to possible transfer of corrosive fluids that may cause chemical burns or toxicity if swallowed. Seek medical care if you or your child were exposed to moisture coming from the device or experience any symptoms related to this device failure.
** Recall Press Release: TW4115 Black Fungus (Nam Meo)
AH USA GROUP INC. is recalling its TW4115 Black Fungus (Nam Meo) product due to possible contamination. The recall is being conducted in cooperation with the California Department of Public Health and is being taken as a precautionary measure to ensure the safety and health of our consumers. Distribution:
The recalled TW4115 Black Fungus (Nam Meo) product was distributed in the following states: California, Florida, Texas, Illinois, Georgia, Washington, Arizona, Louisiana, Wisconsin, Ohio, Oklahoma, and Pennsylvania. through small grocery stores. Golden Koi’s Black Fungus are distributed by AH USA GROUP INC., this brand of Black fungus has a shelf life best buy date of October 2024. Packaged in a sized container of 2.5 OZ. The item code for this product is TW4115.
** UPDATE – Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry
Due to Company Shutdown
Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the Quality activities of these marketed products. (Refer to Attachment I and II*). The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.
Risk Statement: The discontinuation of the Quality program would result in the company’s inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products.
Akorn has not received any reports of adverse events related to this recall.
** Chang Farm Recalls Mung Bean Sprouts Because of Possible Health Risk
Chang Farm, 301 River Road, Whatley, MA is issuing a voluntary recall of Mung Bean Sprouts; all 10lb bags (as some bags may not have sell-by dates), as well as 12 oz retail bags, both packaged on April 23rd, 2023 (distributed on April 24th, 2023), produced by Chang Farm, with the specific sell-by date of May 7th, 2023 because of the possible presence of Listeria monocytogenes (L. Monocytogenes) contamination. 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 headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. The affected product is packaged in 10 lb bags (bulk) with no specified “Sell By” dates and 12 oz plastic bags (retail), labeled under the Chang Farm Brand as Premium Bean Sprouts and have a “Sell By” date of May 7th, 2023.
** This same condiment was recalled last summer as well. This is the second time the squeezable Mighty Sesame Organic Tahini sauce has been recalled in the past nine months.
In Aug. 2022, the FDA released an alert announcing that Rushdi Food Industries was voluntarily recalling the same product because of a potential Salmonella contamination. The previously recalled tahini sauces were part of the same lot, but had an expiration date of March 28, 2023.
“This recall was initiated when the company received a notification by the FDA and the West Virginia Department of Health of the potential presence of Salmonella in this specific lot. The company has received no reports of illness or injury to date,” the agency said in its alert last summer. “The facility reviewed cleaning procedures, environmental monitoring program results, process flow and possible root of contamination without any positive findings.”
Read the original article on Best Life.
** Recall Notice – SD Biosensor, Inc. Requests Discontinuation of Use and Disposal of Specific Pilot™ COVID-19 At-Home Tests in the United States Due to Microbial Contamination in the Liquid Buffer Solution
SEOUL, South Korea, May 4, 2023 /PRNewswire/ — SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits).
The affected tests can be identified by the lot number on the outer packaging and should be appropriately discarded. Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.
Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness. To date, no such illness has been reported. If the liquid in the tube contacts your skin and eyes, flush with large amounts of water and if irritation persists, seek medical attention.
** Lancaster Foods Announces Voluntary Recall of Various Expired Kale, Spinach and Collard Green Products Due to Potential Health Risk
Lancaster Foods is voluntarily recalling a limited quantity of 3 brands of already-expired Robinson Fresh, Lancaster, and Giant brand Kale, Spinach and Collard Green products produced at the company’s Jessup, Maryland facility. This recall is due to a possible health risk from Listeria monocytogenes. No related illnesses have been reported to date. The recalled products are beyond their “Best If Used By Date”.Listeria monocytogenes 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 headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Consumers with these symptoms should immediately consult their health care provider.
** Weinstein Wholesale Meats, Inc. Recalls Raw Ground Beef Burger Products Due to Possible Foreign Matter Contamination Weinstein Wholesale Meats, Inc., a Forest Park, Ill. establishment, is recalling approximately 2,122 pounds of raw ground beef burger products that may be contaminated with extraneous materials, specifically pieces of white neoprene.
** 011-2023, Elkhorn Valley Packing Recalls Boneless Beef Chuck Product Due to Possible E. coli O103 Contamination (Mar 24, 2023)
** Rushdi Foods Issues a Voluntary Recall on One Lot of Their Mighty Sesame Organic Tahini 10.9 oz Squeeze Bottle
Bayonne, NJ. (May 3, 2023) – Rushdi Food Industries, an Israeli based manufacturer, is voluntarily recalling their Mighty Sesame 10.9 Oz Organic Tahini (Squeezable) with the specific expiration date of 9/25/23 due to potential Salmonella contamination. 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 severs illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall was initiated when the company received a notification by the FDA and the Ohio Department of Health of the potential presence of Salmonella in this specific lot. The company has received no reports of illness or injury to date. We immediately informed all Stores who had purchased this product within this lot code about this Recall and instructed them to remove any product which might be on their shelves.
|** Family Dollar is Initiating a Voluntary Recall of Certain Over-the-Counter Drug Products Because the Products Have Been Stored Outside of Labeled Temperature Requirements Family Dollar is initiating a voluntary retail level product recall of certain over-the-counter drug products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to certain stores on or around June 1, 2022 through March 31, 2023 due to product being stored by Family Dollar outside of labeled temperature requirements. |
To date, Family Dollar is not aware of any consumer complaints or reports of illness related to this recall. Products covered by this retail level recall are: 0901458 ADVIL 200MG TABLET 100CT 0901839 ADVIL 200 MG CAPLET 24 CT
0902867 ADVIL DUAL ACTION 36CT CAPLET 0913023 ADVIL TABLET 50CT
0916071 ADVIL LIQUID GEL 40 CT
0999259 ADVIL TABLET 6CT
0999841 ADVIL LIQUI GEL MINIS 20CT
** FOR IMMEDIATE RELEASE – [NEW YORK, NY] May 01, 2023 – Del Maguey Co., New York, NY is conducting a voluntary recall of certain ceramicware cups called copitas – small artisan cups traditionally used for drinking mezcal – because they may exceed FDA guidance levels for leachable lead. Information on Lead: Lead is a toxic substance present in our environment in small amounts and everyone is exposed to some lead from daily actions such as inhaling dust, eating food, or drinking water. In general, the small exposure to lead within the U.S. population does not pose a significant public health concern. However, exposure to larger amounts of lead can cause lead poisoning. While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age. Exposure to extremely high amounts of lead may result in overt and possibly severe symptoms for which an individual is likely to seek medical attention. However, infants, young children and the developing fetus can be affected by chronic exposure to amounts of lead that may not result in obvious symptoms of lead poisoning.
Del Maguey Issues Voluntary Recall of Promotional Ceramicware Cups Called ‘Copitas’ — Used for Drinking Mezcal Because of Possible Health Risk
** Gold Medal flour recall: General Mills issues warning over salmonella presence https://www.msn.com/en-us/health/nutrition/gold-medal-flour-recall-general-mills-issues-warning-over-salmonella-presence/ar-AA1aANYm?ocid=msedgntp&cvid=86ffe9cc1a1c40a19d47fd490b3099f7&ei=10
** TruVision Health LLC is recalling the dietary supplement products listed below because they contain the unapproved dietary ingredients hordenine and/or octodrine/DMHA (1,5-Dimethylhexylamine). Hordenine is possibly unsafe when taken by mouth and might cause stimulating side effects such as rapid heart rate, high blood pressure, jitteriness, nervousness, nausea, vomiting or insomnia. These adverse events are more likely to occur in sensitive sub-populations of people such as pregnant women and consumers with cardiovascular disease. Currently, hordenine is not an approved dietary ingredient in dietary supplements.
** Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers/consumers/retailers. Akorn is requesting destruction of any recalled products. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.
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