Nostrum Laboratories Expands Recall of Metformin HCl Extended Release Tablets

January 11, 2021
Pharmaceutical Technology Editors

The company is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.

Nostrum Laboratories, Inc. announced on Jan. 4, 2021 that it is expanding its recall from Nov. 2, 2020 to include one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of levels of nitrosamine impurities above the ADI limit of 96 ng/day. The impurity, N-nitrosodimethylamine (NDMA), is considered a probable human carcinogen.

The recalled product, which is used to improve blood glucose control in adults with type 2 diabetes mellitus, is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. It was distributed to nationwide wholesalers. The company stated in a press release that it has not received any notices of adverse events related to the recall. Adverse events may be reported to FDA via the agency’s MedWatch Adverse Event Reporting Program.

Source: FDA