FDA Update on Recall of Valsartan-containing Products

PUBLISHED: Jul 31, 2018
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) is updating health care professionals and patients after discovering that several additional companies that repackage drug products are also recalling valsartan-containing products.

FDA has product recall information from three additional repackagers of valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc. – labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack – and the agency has added them to the recalled products list. Two of these companies, A-S Medication and RemedyRepack, may also distribute valsartan products not affected by the recall. The agency is confirming this information and will provide an update once it is available.

The following additional repackagers are recalling or are expected to recall valsartan-containing products. FDA is working to gather product recall information from these companies and has removed them from the list of products that are not impacted by this recall:

  • Bryant Ranch Prepack Inc.
  • H. J. Harkins Company Inc. (this company was not originally included on either list)
  • Lake Erie Medical, doing business as Quality Care Products LLC
  • NuCare Pharmaceuticals Inc.
  • Northwind Pharmaceuticals
  • Proficient Rx

It is possible that not all valsartan-containing products repackaged by these companies are impacted by the recall. FDA continues to evaluate valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available.

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