Nostrum Laboratories Inc., based in Kansas City, Missouri, announced Monday that it voluntarily recalls the HCl metformin extended-release tablet, USP 750 mg, according to a recall notice issued by the Food Administration. Published by US Pharmaceutical & Pharmaceutical Products.
Tests showed nitrosamine, or NDMA, levels exceeded acceptable limits in the recalled tablets.
NDMA chemicals are considered by the US Environmental Protection Agency to cause cancer. It is an organic chemical used to make liquid rocket fuel and it can be a byproduct of manufacturing processes, including the manufacture of pharmaceuticals. It is also found in water and foods, including meat, dairy, and vegetables.
NDMA has also been found in some blood pressure medications and antacids.
This is the latest in a series of metformin recalls that have involved potentially carcinogenic contaminants in drugs.
Nostrum said it has not received any reports of adverse events related to the recall. The company also said it is informing distributors and arranging a return of recalled product.
Affected product is packaged in 1
00-tablet HDPE bottles, according to NDC 29033-056-01. Metformin HCl extended-release tablets affected, lot USP 750 mg according to NDC 29033-056-01, batch numbers MET200101 and MET200301, expiration date 05/2022. It can be identified as a light white oblong pill with the word “NM7.”
More than 34 million people in the US have diabetes – about 1 in 10 – with about 90 to 95% of them diagnosed with type 2 diabetes, according to the US Centers for Disease Control and Prevention.