Metformin XR Warning due to NDMA impurity

Some brands of long acting Metformin are being recalled since they contain higher than acceptable levels of NDMA (see list below).

The U.S. Food and Drug Administration has recommended recalls of certain metformin products that may contain the impurity N-nitrosodimethylamine (NDMA) above the acceptable intake limit.

Patients taking recalled 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.

Remind patients not to stop medication until they check with their provider.

Find more info on the FDA Website here

Recalled Products

  • The agency is also asking all manufacturers of extended release versions of metformin to evaluate their risk of excessive NDMA and to test at-risk product before each batch is released onto the U.S. market. If testing shows NDMA above the acceptable intake limit, the manufacturer must inform the agency and should not release the batch to the U.S. market.
  • FDA’s testing has shown elevated levels of NDMA in some extended release (ER) metformin formulation but not in the immediate release (IR) formulation or in the active pharmaceutical ingredient.

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