Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended-Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets).
According to a notice by the U.S. Food and Drug Administration, the Metformin HCl Extended-Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to 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.
The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01.
|Product Description||NDC||Lot Number||Expiry Dates|
|Metformin HCl Extended Release Tablets, USP 750 mg
(generic equivalent to Glucophage Tablets)
The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) was distributed Nationwide to wholesalers.
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.
For more information on the recall, click here