Drug Safety Alerts

Lupin Pharmaceuticals, Inc.Metformin Hydrochloride Extended-Release 500 mg tablets - Consumer-level Recall

6/10/2020

On June 10, 2020, Lupin Pharmaceuticals, Inc. issued a consumer‑level recall of Metformin Hydrochloride Extended-Release 500 mg tablets NDC # 68180‑0336‑07 that was distributed in the United States. This recall was issued due to the detection of N-nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

This could be a health hazard or safety risk to patients using product affected by this recall.

This recall affects lot number G901203 exp. 12/2020.

NDMA is classified as a probable human carcinogen based on laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, including meats, dairy products, and vegetables. Metformin is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients taking recalled Metformin Hydrochloride Extended-Release tablets are advised to continue taking their medication and contact their health care professional who can prescribe a replacement. According to the FDA, it could be dangerous for patients with type 2 diabetes to stop taking their Metformin without first talking to their health care professionals.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Metformin Hydrochloride Extended-Release 500 mg tablets to contact their prescriber.

For more information, please contact Inmar Rx, Inc. at 1-855-532-1856, Monday through Friday, 9:00 am through 5:00 pm (ET). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.