Amneal Pharmaceuticals LLC has issued a voluntary nationwide recall for the extended-release version of the diabetes drug metformin (USP 500-mg and 750-mg) due to high levels of a cancer-causing chemical.
The recalls were issued after Amneal was notified by the FDA that 7 lots of Metformin ER tested positive for unacceptably high amounts of a carcinogenic chemical called N-Nitrosodimethylamine (NDMA).
In response, Amneal recalled those 7 lots, and extend the recall to all lots of metformin ER (500-mg and 750-mg) out of an “abundance of caution.” Amneal did not report any injuries due to the recalled drugs.
In March, the online pharmacy Valisure tested metformin for NDMA and found that 16 batches from 11 manufacturers contained unsafe levels of the carcinogen.
The highest amount of NDMA was found in a single lot of metformin made by Amneal Pharmaceuticals — it contained 16.5-times the FDA’s acceptable daily limit of NDMA.
Valisure warned that NDMA contamination in metformin is particularly concerning because it is taken every day for years by patients with type-2 diabetes. Over time, exposure to NDMA may increase a patient’s risk of cancer.
A growing number of lawsuits have been filed against pharmaceutical companies by people who developed cancer after taking medications that were contaminated by NDMA, including Zantac and valsartan.
Source: Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity