| | MedWatch - The FDA Safety Information and Adverse Event Reporting Program | | | TOPIC: Metformin HCl Extended Release Tablets - USP, 750 by Nostrum Laboratories: Recall - Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Nostrum Laboratories is recalling one lot of Metformin HCl Extended Release Tablets - USP, 750 mg because it has been found they contain levels of nitrosamine impurities above the ADI limit of 96 ng/day, as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2, 2020. NDMA is classified as a probable human carcinogen based on results from laboratory tests. To date, Nostrum Laboratories has not received any reports of adverse events related to this recall. For more information about this recall click on red button "Read Recall" below. BACKGROUND: This product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. RECOMMENDATION: - Consumers should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional.
- Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
| | | Health professionals and patients are encouraged to 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 form, or submit by fax to 1-800-FDA-0178.
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