Valsartan Tablets USP 320 mg recalled over manufacturing violations

Recall date

August 15, 2018

Source

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

Official notice title

Preferred Pharmaceuticals, Inc recalls Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250…

Recall number

D-1107-2018

FDA classification

Class II

Brand / firm

Preferred Pharmaceuticals, Inc

Sold / distributed

Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.

Why it was recalled

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9