FDA Updates and Press Announcements on NDMA in Metformin
The FDA is alerting patients and health care professionals to several voluntary recalls of extended release (ER) metformin by the companies listed below. The companies are recalling metformin due to the possibility the medicines could contain nitrosodimethylamine (NDMA) above the acceptable intake limit.
- Granules Pharmaceuticals – 12 lots
- Lupin Pharmaceuticals – All lots (expansion of previous recall)
- Avkare (repackager for Amneal) – All lots
- PD-Rx Pharmaceuticals (repackager for Amneal) – 31 lots
- PD-Rx Pharmaceuticals (repackager for Marksans) – 26 lots
- The Harvard Drug Group (repackager for Apotex) – One lot (T-02134)
- Preferred Pharmaceuticals (repackager for Marksans) – Four lots (J0119M, K1419L, K2719J, A0220H)
FDA published a recalled metformin list including details about metformin products that have been recalled. Patients taking recalled ER metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional. FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate; FDA testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin).