Amlodipine and Valsartan Tablets USP 10 mg/320 mg recalled over manufacturing violations

Recall date

December 31, 2018

Source

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

Official notice title

Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, I…

Recall number

D-0364-2019

FDA classification

Class II

Brand / firm

Aurobindo Pharma USA Inc.

Sold / distributed

Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.

Why it was recalled

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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

What was recalled

Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.