July 14, 2020
The U.S. FDA has announced multiple companies are voluntarily recalling their metformin extended-release (ER) products due to the possible presence of N-nitrosodimethylamine (NDMA) above established daily intake limits.
NDMA is a probable human carcinogen (cancer-causing agent) that has been identified in several types of medication since 2018, including the heartburn medication ranitidine and angiotensin receptor blockers such as valsartan. The FDA announced concerns regarding NDMA in metformin ER in May 2020 based on the results of laboratory tests that found the substance occurring in quantities above the agency’s daily intake limits.
The FDA advises patients who are taking the recalled medication to continue to do so until their prescriber or pharmacist has given them a replacement or switched them to an alternative treatment option. Metformin ER is used to help control blood sugar in patients who have type 2 diabetes, and it may be dangerous for patients to stop taking the medication without first consulting a healthcare professional.
Companies recalling their metformin ER include:
- Granules Pharmaceuticals
- Lupin Pharmaceuticals
- Avkare (repackager for Amneal)
- PD-Rx Pharmaceuticals (repackager for Amneal and Marksans)
- The Harvard Drug Group (repackager for Apotex)
- Preferred Pharmaceuticals (repackager for Marksans)
There is minimal member impact at Benecard Central Fill, and the affected members have been contacted.