Drug Safety Alerts

Nostrum Metformin Expanded Recall

1/25/2021

On January 25, 2021, the United States Food and Drug Administration (FDA) published a notice regarding an expanded consumer-level recall of Metformin Hydrochloride Extended-Release 750 mg tablets NDC # 29033-0056-01 manufactured by Nostrum Laboratories, Inc. This recall was issued because Nostrum Laboratories, Inc. observed that N-Nitrosodimethylamine (NDMA) content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96 ng/day. This recall is an expansion of the previous recalls initiated on November 2, 2020 and January 5, 2021.

This recall affects lot number MET200601 exp. July 2022.

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 found in water and foods, including meats, dairy products and vegetables. Nostrum Laboratories, Inc. has advised that as of the date of its announcement, it has not received any reports of adverse events that have been related to this recall.

Nostrum Laboratories, Inc. advises that consumers taking these recalled product lots of Metformin ER Tablets should contact their healthcare professional to obtain a replacement or alternative treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional. Nostrum Laboratories, Inc. further advises that consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

CVS Caremark Response: Because of this action, CVS Caremark® is sending letters to members who received this product through CVS Caremark® Mail Service Pharmacy and their physicians

For more information about this recall, please contact Nostrum Laboratories, Inc. at 1-816-308-4941, Monday through Friday, 8:00 AM to 5:00 PM (CT) or email quality@nostrumpharma.com. You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.