FDA Orders 5 Firms to Recall Metformin

FDA says five drug firms will need to recall their metformin for diabetes drug products after sampling detected the impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit (see earlier story). The agency contacted the firms and their recall notices will be posted accordingly on FDA’s Web site. “There are additional manufacturers of the metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled,” it says.

The agency notes that patients should continue taking metformin tablets even after recalls occur, until they consult with their health care professional who can prescribe a replacement. Patients with Type 2 diabetes could face dangerous health risks if they stop taking their prescription drug. It also recommends that health care professionals continue to prescribe metformin when clinically appropriate.