Viona Pharmaceuticals, Inc., has recalled two lots of Metformin Hydrochloride Extended- Release Tablets, USP 750mg due to the detection of N-nitrosodimethylamine (NDMA) impurities above acceptable daily limits. Cadila Healthcare Limited manufactured the product in November 2019 for Viona to distribute.
NDMA is considered a probable human carcinogen (a substance that could cause cancer) and is a known environmental contaminant found in water and food. According to the recall announcement, patients who may have the affected metformin in their possession should not stop taking their medication without consulting a healthcare professional. The risk of stopping treatment with metformin, which is used to treat type 2 diabetes, may outweigh the risk of potential NDMA exposure. As of the date of the recall, Cadila and Viona had not received reports of adverse events related to the affected product.
Consumers can direct questions regarding the recall to Eversana Life Science Services at 1-888-304-5022 (option 1). They should contact their healthcare provider if they’ve experienced any problems that may be related to using the product and can also direct medical-related questions or report adverse events or quality issues to Viona at 1-888-304-5011. Adverse events can be reported to the U.S. FDA through the agency’s MedWatch program.
A full copy of the recall announcement with details of the affected lots is available on the FDA’s website.
There is no member impact through Benecard Central Fill.
