WASHINGTON (dpa-AFX) - Nostrum Laboratories, Inc. has recalled type 2 diabetes drug Metformin as N-Nitrosodimethylamine or NDMA, a probable human carcinogen, exceeds acceptable daily intake or ADI limit established by the U.S. Food and Drug Administration.
The recall involves 2 lots each of Metformin HCl Extended Release tablets USP 750 mg and 500 mg to the consumer level.
The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. These are packaged in HDPE bottles of 100 tablets.
The affected Metformin 750 mg tablets are with lot numbers MET200101 and MET200301 with expiry dates 05/2022, and 500 mg tablets are with lot numbers MET100201 and MET100401 with expiry dates 05/2022. These drugs were distributed Nationwide to wholesalers.
The Kansas City, Missouri- based company noted that the drugs have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day. . NDMA, a known environmental contaminant, is classified as a probable human carcinogen, a substance that could cause cancer. It is generally found in water and foods, including meats, dairy products, and vegetables.
Nostrum has not received any reports of adverse events related to this recall to date.
Consumers are asked to consult a healthcare professional to obtain a replacement or a different treatment option.
The FDA began testing Metformin in the U.S. supply after it become aware of NDMA in some Metformin products in other countries in late 2019. The FDA later urged many drug companies that manufacture Metformin to implement the drug's recall due to NDMA impurity.
Recently, in September this year, Sun Pharmaceutical Industries, Inc. recalled one lot of type 2 diabetes medication RIOMET ER (metformin), and in July India-based Lupin Pharmaceuticals Inc. called back all batches of Metformin.
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