The U.S. Food and Drug Administration recommends health professionals and patients report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
Read more below:
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.