FDA DRUG RECALL UPDATE: Valsartan-containing products

Date: 12/31/18

On December 31, 2018, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of Valsartan products from Aurobindo Pharma USA.

The FDA press release states the following:
Aurobindo Pharma USA, Inc. is voluntarily recalling 80 lots of Valsartan-containing products within expiry. The lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 2 lots of Valsartan Tablets, USP (320mg strength) and 52 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths). Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Aurobindo Pharma. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC). The finished products are manufactured by Aurobindo Pharma USA Inc.

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., Senior Manager, Clinical Pharmacy Operations, at 818-676-6959, or email at Taline.Jaghasspanian@EnvolveHealth.com.

Read the Full FDA Announcement Here