Nov, 2020 – Nostrum Laboratories, Inc. is recalling two lots of 500mg metformin HCl extended-release tablets and two lots of 750mg metformin HCl extended-release tablets. They were found to contain unsafe levels of NDMA (N-Nitrosodimethylamine), a probable human carcinogen. This is the latest drug recall over concerns about NDMA. Most notably, popular heartburn medication Zantac was recalled earlier this year.
The latest metformin recalls are among several extended-release versions of the common type 2 diabetes treatment in recent months initiated after testing revealed NDMA in levels above what the Food and Drug Administration (FDA) deems safe for daily consumption. Consumption of NDMA at higher levels may put consumers at risk for cancer, the agency cautioned.
Recalled Metformin Products
The recall involves the following drug products:
- Metformin HCl Extended Release Tablets, 500mg, NDC 29033-055-01, Lot number MET100201, Expiration Date 05/2022
- Metformin HCl Extended Release Tablets, 500mg, NDC 29033-055-01, Lot number MET100401, Expiration Date 05/2022
- Metformin HCl Extended Release Tablets, 750, NDC 29033-056-01, Lot number MET200101, Expiration Date 05/2022
- Metformin HCl Extended Release Tablets, 750, NDC 29033-056-01, Lot number MET200301, Expiration Date 05/2022
Patients who have affected products should consult with their doctors to get a replacement or different replacement options. The FDA cautions that it could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their doctors.
History of NDMA Concerns in Medication
Concerns over NDMA first surfaced in 2018 when the impurity was found in some high blood pressure and heart failure drugs known as ARBs, which was later linked to contamination during the manufacturing process.
Last year, NDMA was found in the heartburn drug Zantac and other drugs containing ranitidine, which resulted in sweeping recalls and the eventual withdrawal of the drugs this year when it was determined that levels of NDMA could increase to unsafe levels even under normal storage conditions. On April 2, 2020, the FDA recommended the removal of all prescription and over-the-counter versions of ranitidine, the active ingredient in the heartburn and acid reflux medicine Zantac, as well as generics.