Camber Pharmaceuticals recalled over manufacturing violations

Recall date

August 8, 2018

Source

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

Official notice title

Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceutica…

Recall number

D-1116-2018

FDA classification

Class II

Brand / firm

Hetero Labs Limited Unit V

Sold / distributed

Nationwide

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

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902