Nostrum Laboratories issues voluntary recall of contaminated metformin products
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Nostrum Laboratories, Inc., is voluntarily recalling two lots of metformin hydrochloride extended-release tablets that contain unacceptable levels of the nitrosamine impurity N-Nitrosodimethylamine, or NDMA, according to an FDA statement.
In the announcement, the company stated the lots of metformin HCl extended-release tablets, USP 500 mg 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.
NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.
The product is packaged in HDPE bottles of 100 tablets, under NDC 29033-055-01. The affected metformin HCl extended release tablets are lot numbers MET100201 (expiration May 2022) and MET100401 (expiration May 2022).
Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Consumers should consult a health care professional to obtain a replacement or a different treatment option. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
As Healio previously reported, the FDA in May asked five drug manufacturers to voluntarily recall several lots of extended-release metformin after agency lab testing revealed unacceptable levels of NDMA.
On Oct. 9, the FDA provided an update to this recall to include two voluntary recalls by Marksans Pharma and Sun Pharmaceutical Industries for extended release metformin due to NDMA levels above the acceptable intake limit. The October recall affected 76 additional lots of 500 mg and 750 mg of metformin ER tablets manufactured by Marksans and one lot of 500 mg per 5 mL of Riomet ER manufactured by Sun, according to the FDA.
Nostrum Laboratories is the sixth company to issue a voluntary recall of metformin hydrochloride extended-release tablets since June; in addition to Marksans Pharma and Sun Pharmaceutical Industries, other companies were Amneal Pharmaceuticals, Apotex Corp, and Teva Pharmaceuticals USA.
Consumers with medical questions regarding the Nostrum Laboratories recall can contact Nostrum Laboratories, Inc. medical affairs at 816-308-4941or email quality@nostrumpharma.com.
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