September 03, 2020
Bayshore Pharmaceuticals is voluntarily recalling two lots of metformin hydrochloride extended-release tablets due to the detection of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, at levels above the acceptable daily intake limit. The recall is included in the September 2, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were manufactured by Beximco Pharmaceuticals Limited and distributed throughout the United States by Bayshore Pharmaceuticals:
- metformin hydrochloride extended-release tablets, 500 mg, 1000 tablets (NDC 76385-128-10), from lot 18641 (Exp. 5/21); and
- metformin hydrochloride extended-release tablets, 750 mg, 100 tablets (NDC 76385-129-01), from lot 18657 (Exp. 5/21).
Bayshore Pharmaceuticals initiated the recall August 19, 2020. On August 25, 2020, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
“To date, neither Bayshore nor Beximco have received any reports of adverse events related to use of the product,” Bayshore Pharmaceuticals stated in an August 19, 2020, company announcement.
Metformin is a prescription medication used to help control blood sugar levels in people with type 2 diabetes.