FDA DRUG RECALL UPDATE: VALSARTAN AND VALSARTAN-HYDROCHLOROTHIAZIDE

Date: 08/15/18

On August 9, 2018, the U.S. Food and Drug Administration (FDA) updated their announcement regarding the valsartan voluntary recall to include an additional manufacturer.

The FDA press release states the following:

FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall to incorporate recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc. Not all Camber valsartan products distributed in the U.S. are being recalled. Camber Pharmaceuticals is recalling certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). Hetero Labs manufactures the API for the Camber products using a process similar to Zhejiang Huahai Pharmaceuticals. Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang. FDA is testing samples of valsartan API and finished products to confirm the extent and amount of NDMA and help inform the ongoing investigation. The agency has also contacted other manufacturers of valsartan API to determine if their manufacturing processes are at risk for the formation of NDMA, and is working with them to ensure NDMA is not present in future valsartan API.

If you have any questions or concerns about Envolve Pharmacy Solutions’ response to the product recall, please contact Nelson Aragon, Pharm D, Drug Utilization Review Clinical Pharmacist, at (800) 225-2573, ext. 809-3034 or e-mail at Nelson.Aragon@envolvehealth.com, or contact Taline Jaghasspanian, Pharm D, Manager, Clinical Pharmacy Operations, at (818) 676-6959, or email at Taline.Jaghasspanian@centene.com.