FDA Recalls of Extended Release (ER) Metformin Several Companies 

FDA Recalls of Extended Release (ER) Metformin Several Companies 
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FDA Recalls of Extended Release (ER) Metformin Several Companies 

 

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) – All lots
  • PD-Rx Pharmaceuticals (repackager for Marksans) – All 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).

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 testing has found NDMA in certain lots of extended release (ER) metformin and is recommending companies recall lots with levels of NDMA above the acceptable intake limit of 96 nanograms per day.

For reference, consuming up to the acceptable daily intake limit, 0.096 micrograms (96 nanograms), of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. NDMA may increase the risk of cancer if people are exposed to it above the acceptable level and over a long period of time, but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.

 

Click Here for list of recalled metformin products

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