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FDA Updates and Press Announcements on NDMA in Metformin

Search metformin products recalls list

QA on NDMA in metformin

Nitrosamine Impurities in Medications


Update [7/13/2020] 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).
 

FDA-published testing method to provide an option for regulators and industry to detect NDMA impurities
The links below are to FDA-published testing methods to provide an option for regulators and industry to detect nitrosamine impurities in metformin drug substances and drug products. These methods should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.
  • LC-HRMS method: an LC-MS method for the detection of NDMA in metformin drug substance and drug products.
  • LC-ESI-HRMS method: an LC-HRMS method for the measurement of amounts of eight nitrosamine impurities in metformin drug substance and drug products

 

 

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