Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC…

Recall date

December 31, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1035-2019

FDA classification

Class II

Brand / firm

Aurobindo Pharma USA Inc.

Sold / distributed

Product was distributed to major distribution chains throughout the United States.

Why it was recalled

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90