FDA Recalls for the Week of October 25

FDA Recalls on Drugs

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.  NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to SAI related to this recall.

FDA Recalls on Food & Beverages

Natural Grocers Issues Voluntary Recall on Organic Elderberries Due to Potential Presence of Salmonella

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery retailer, is voluntarily recalling Natural Grocers Brand 4-ounce Organic Whole Elderberries after being notified by its supplier of the potential presence of Salmonella. Salmonellais an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. If you are experiencing these symptoms, and believe you may have been exposed to Salmonella, please report to a medical provider.

Homestead Creamery Issues Voluntary Glass Bottled Product Recall

Homestead Creamery of Wirtz, VA is voluntarily recalling glass bottled products because of a suspected issue with the bottle sanitizing process. Glass bottled product in question may have a strong sanitizer odor which may affect the taste and quality of the product. There is no known health risk associated with the issue at this time.

Russ Davis Wholesale Issues Allergy Alert on Undeclared Egg in Mixed Veggie Cup With Dip

Russ Davis Wholesale of Wadena, Minnesota is recalling individual serving cups of Mixed Veggie Cup with Dip because it may contain undeclared Egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

The Mixed Veggie Cup with Dip was distributed in Colorado, Kansas, South Dakota, Wyoming, New Mexico in higher education, health care and corporate campus’ in grab ‘n go coolers.

Allergy Alert Issued for Undeclared Egg in Prepared Macaroni & Cheese Sold at Whole Foods Market Stores in Five States

Whole Foods Market is voluntarily recalling select prepared Macaroni & Cheese products from stores across five states because they contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

The affected products were sold at Whole Foods Market stores in Maryland, New Jersey, Pennsylvania, Virginia and Washington, D.C. The product was sold in plastic containers and in family-style meal kits with Whole Foods Market scale labels in the prepared foods department, available both hot and refrigerated. The product was also available from the chef’s case counter and from Whole Foods Market online and catering menus.

FDA Recalls on Medical Devices

Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)

Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods may impair infusion pump functionality and performance. Baxter previously communicated this information to customers directly in a Safety Alert on April 1, 2020 and subsequently via an Urgent Device Correction notification on August 28, 2020.

Deviations from the cleaning methods described in product-specific Operator’s Manuals may lead to residue buildup or corrosion of the electrical pins (e.g. depressed pins) on the infusion pump rear case and battery electrical contacts. This could result in notifications that the user should check the battery, or that batteries are not charging or holding their charge. If a device has residue buildup or corrosion, and is running solely on battery power, the pump may shut down without alarming or alerting the user. An undetected or abrupt discontinuation in medication delivery may lead to a delay or interruption of intended treatment. Depending on various factors, including the medication being infused, the volume and rate of the infusion, the route of administration, and patient status and comorbidities, this could result in serious adverse health consequences or death. To date, Baxter has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion.

You can find all FDA recalls at the FDA website.