July 09, 2020
The Harvard Drug Group and Preferred Pharmaceuticals Inc. recently joined several other firms voluntarily recalling metformin hydrochloride extended-release tablets after a US Food and Drug Administration (FDA) analysis detected an N-Nitrosodimethylamine (NDMA) impurity above an acceptable level. The latest recalls were included in the July 8, 2020, FDA Enforcement Report.
On June 12, 2020, The Harvard Drug Group initiated a recall of 1906 cartons of metformin hydrochloride extended-release tablets, 500 mg, 100-tablet cartons (NDC 00904-5794-61) from lot T-02134 (Exp. 9/20). The tablets were manufactured by Apotex Inc. for Apotex Corp. and were distributed throughout the United States by Major Pharmaceuticals.
On June 17, 2020, Preferred Pharmaceuticals initiated a recall of 144 bottles of metformin hydrochloride extended-release tablets, 500 mg, 100 count (NDC 68788-6932-01), from lots J0119M, K1419L, K2719J, and A0220H (Exp. 12/20). The tablets were manufactured by Time-Cap Labs Inc. and distributed to two medical clinics in Florida.
On June 26, 2020, the FDA designated both recalls 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.
Metformin is a prescription medication used to help control blood sugar levels in people with type 2 diabetes.