Nostrum Laboratories Inc., based in Kansas City, Missouri, announced Monday that it is voluntarily recalling its metformin HCl extended release tablets, USP 750 mg, according to a
recall posted by the US Drug & Food Administration.
recall posted by the US Drug & Food Administration.
Testing revealed levels of
nitrosamine, or NDMA, above acceptable limits in the recalled tablets.
nitrosamine, or NDMA, above acceptable limits in the recalled tablets.
The chemical NDMA is considered a possible carcinogen by the
US Environmental Protection Agency. It’s an organic chemical used to make liquid rocket fuel and it can be a byproduct of manufacturing, including pharmaceutical manufacturing. It’s also found in water and foods, including meats, dairy and vegetables.
US Environmental Protection Agency. It’s an organic chemical used to make liquid rocket fuel and it can be a byproduct of manufacturing, including pharmaceutical manufacturing. It’s also found in water and foods, including meats, dairy and vegetables.
NDMA has also been found in certain blood pressure drugs and antacid.
This is the latest in a
series of metformin recalls linked to potentially cancer-causing contaminants in the drugs.
series of metformin recalls linked to potentially cancer-causing contaminants in the drugs.
Nostrum said it has not received any reports of adverse events related to the recall. The company also said it was notifying its distributors and arranging for the return of the recalled product.
The impacted product is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg lots are under NDC 29033-056-01, lot numbers MET200101 and MET200301 which expiration date 05/2022. It can be identified as an off-white oblong tablet debossed with “NM7.”
More than 34 million people in the US have diabetes — about 1 in 10 — with approximately 90 to 95% of them being diagnosed with type 2 diabetes, according to the
US Centers for Disease Control and Prevention.
US Centers for Disease Control and Prevention.