Metformin recall due presence of N-Nitrosodimethylamine

METFORMIN RECALL

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

A MedWatch Safety Alert was added to the FDA Recalls webpage.  TOPIC: Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg by Teva: Recall - Due to the Detection of N-Nitrosodimethylamine AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: Teva is recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests and is known as an environmental contaminant of foods and water. The affected Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg are described in the recall. Please click on the Read Recall Button below for product description, lot numbers and expiration dates. Pictures of the labels are included below. BACKGROUND: Metformin Hydrochloride Extended-Release Tablets USP, is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.