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Recalls That Should Be on Your Radar—Week of May 5, 2019

We’ve rounded up a list of important US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) recalls from this past week.

Tyson Foods Expands Recall of Chicken Strips With Possible Foreign Matter Contamination

Tyson Foods, Inc., a Rogers, Ark. establishment, is recalling approximately 11,829,517 pounds of frozen, ready-to-eat chicken strip products that may be contaminated with extraneous materials, specifically pieces of metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, ready-to-eat chicken strip items were produced on various dates from Oct. 1, 2018 through March 8, 2019 and have “Use By Dates” of Oct. 1, 2019 through March 7, 2020.

The products subject to recall bear establishment number “P-7221” on the back of the product package. These items were shipped to retail and Department of Defense locations nationwide, for institutional use nationwide and to the U.S. Virgin Islands.

Read more about this recall here.

Vivimed Life Sciences Issues Recall for Losartan Potassium Due to Possible NMBA

Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level due to the detection of an N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer) 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 containing high levels of the impurity NMBA cannot be ruled out.

This product is made by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage). To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall.

Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage).

Read more about this recall here.

Par Pharmaceutical, Inc. Issues Recall for Mycophenolate Mofetil for Injection Due to Presence of Glass

Endo International plc, announced today that one of its operating companies, Par Pharmaceutical, Inc., is voluntarily recalling one lot of Mycophenolate Mofetil for Injection, USP to the hospital and retail pharmacy level. One vial of product was observed containing a glass fragment after reconstitution.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, Par Pharmaceutical, Inc. has not received any reports of adverse events related to this recall.

Mycophenolate Mofetil for Injection, USP is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate Mofetil for Injection, USP should be used concomitantly with cyclosporine and corticosteroids. The affected Mycophenolate Mofetil for Injection, USP includes lot AD812, expiry 09/2020. The product, manufactured for Par Pharmaceutical, Inc. by Gland Pharma Limited, is packaged in cartons of 4 single use vials with NDC 42023-172-04. Mycophenolate Mofetil for Injection, USP, lot AD812 was distributed nationwide in the U.S. to wholesale distribution locations between January 23, 2019, and February 11, 2019.

Read more about this recall here.

Stiff Boy LLC Issues Recall of THE BEAST Capsules Due to Presence of Undeclared Sildenafil

STIFF BOY LLC. is voluntarily recalling all lots within expiry of The Beast capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an FDA approved drug for the treatment of male erectile dysfunction and is in a class of drugs called phosphodiesterase (PDE-5) inhibitors.

The presence of sildenafil in THE BEAST Capsules renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Consumption of a product with undeclared PDE-5 inhibitors may pose a threat to consumers because the active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels which can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. To date, STIFF BOY LLC. has not received any reports of adverse events related to this recall.

Read more about this recall here.

Mecox Bay Dairy, LLC Issues Recall for “Mecox Sunrise” Cheese Due to Listeria Risk

Out of an abundance of caution, Mecox Bay Dairy, LLC, is recalling their Mecox Sunrise washed-rind Tomme style 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 monocytogenes infection can cause miscarriages and stillbirths among pregnant women.

This cheese was distributed and sold at seven retail locations and one restaurant on Eastern Long Island, NY, and served at one restaurant in Chicago, IL. The product comes in a clear plastic package marked with “Mecox Sunrise” cheese label. As of the date of this release, all affected Mecox Sunrise has been removed from all stores and restaurants.

No illnesses have been reported to date in connection with this problem. The potential for contamination was noted after routine testing by New York State Agriculture and Markets Division of Milk Control revealed the presence of Listeria monocytogenes in a sample of Mecox Sunrise cheese.

Read more about this recall here.