Another drug company has recalled two lots of metformin, a drug widely used for type 2 diabetes, because it contains a potentially carcinogenic impurity.
Nostrum Laboratories of Kansas City, Mo., is intentionally recalling two lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg.
According to an announcement with the United States Food and Drug Administration, the drug “was found to contain levels of nitrosamine impurities above the ADI limit of 96 ng / day as published in the FDA guidance document released in September 2020”.
“NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the results of laboratory tests. NDMA is a known environmental contaminant found in water and food, including meats, dairy products, and vegetables.
For almost a year, the United States Food and Drug Administration has been posting metformin recall announcements. You can see the full list of metformin recalls here.
The drug was distributed nationwide to wholesalers. The tablet is off-white, oblong in shape and debossed with “NM7”.
Product details are:
- Metformin Hydrochloride Prolonged-Release Tablets, USP 750 mg, NDC number 29033-056-01, lot numbers MET200101 and MET200301, both lots expire in May 2022.
For more information, contact Nostrum Laboratories, Inc. Medical Affairs at 816-308-4941 or email [email protected], 8 a.m. to 5 p.m. CST, weekdays.