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January 10, 2022January 7, 2022 – Viona Pharmaceuticals has recalled 33 lots of Metformin Hydrochloride Extended- Release Tablets, USP 750mg, due to N-nitrosodimethylamine (NDMA) amounts outside of specification.
- There is no impact to members through Benecard Central Fill.
- NDMA is classified as a probable human carcinogen (a substance that may cause cancer) and a known environmental contaminant found in water and foods. It has been identified in metformin and other medications, such as valsartan and ranitidine, and has been the source of numerous recalls in recent years. Metformin is indicated as an adjunct to diet and exercise to improve blood sugar control in adults who have type 2 diabetes.
- Viona recommends that patients in possession of the recalled metformin 750mg continue taking their medication and contact their healthcare provider for advice on alternative treatment. The FDA has cautioned that stopping metformin without first seeking advice from a healthcare provider could present a greater risk to patients than NDMA exposure. As of the recall date, Viona has received no reports of adverse events related to the affected product.
- Questions regarding the recall should be directed to Inmar Pharmaceutical Services by phone at 1-855-249-3303, option 1. Consumers can contact Viona with medical-related questions or to report an adverse event or quality issues at 1-888-304-5011. Viona recommends that consumers contact a healthcare provider if they have experienced any problems that may be related to use of the recalled metformin.
- A copy of the recall announcement, including affected lot numbers, is available on the FDA's website. The FDA also provides detailed information on metformin NDMA recalls on the site.