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Diabetes Drug Recall Grows


July 02, 2020

Teva Pharmaceuticals USA is recalling metformin hydrochloride extended-release tablets due to a US Food and Drug Administration (FDA) analysis that detected an N-Nitrosodimethylamine (NDMA) impurity above an acceptable level. The recall appeared in the July 1, 2020, FDA Enforcement Report and follows similar metformin recalls from Apotex Inc., AvKARE Inc., and PD-Rx Pharmaceuticals Inc. announced in the June 24, 2020, FDA Enforcement Report.

Teva Pharmaceuticals USA is recalling the following products:

  • metformin hydrochloride extended-release tablets, 500 mg, in 100-count bottles (NDC 62037-571-01) from lots 1329548A (Exp. 6/20), 1338302M (Exp. 10/20), 1348968M (Exp. 10/20), 1348969M (Exp. 10/20), 1348970M (Exp. 11/20), and 1376339M (Exp. 9/21);
  • metformin hydrochloride extended-release tablets, 500 mg, in 1000-count bottles (NDC 62037-571-10) from lots 1323460M (Exp. 6/20), 1330919M (Exp. 6/20), 1338300A (Exp. 10/20), 1341135M (Exp. 12/20), and 1391828M (Exp. 11/21);
  • metformin hydrochloride extended-release tablets, 750 mg, in 100-count bottles (NDC 62037-577-01) from lots 1333338M (Exp. 8/20) and 1333339A (Exp. 8/20); and
  • metformin hydrochloride extended-release tablets, 750 mg, in 1000-count bottles (NDC 62037-577-10) from lot 1354471A (Exp. 2/21).

The recalled products were manufactured by Watson Pharma Private Limited and distributed by Actavis Pharma throughout the United States, including Puerto Rico. 

Teva Pharmaceuticals USA voluntarily initiated the recall June 2, 2020. On June 19, 2020, the FDA designated the recall Class II, communicating use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm. 

Metformin is a prescription medication used to help control blood sugar levels in people with type 2 diabetes.

Jolynn Tumolo

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