Solco Healthcare US Valsartan and Hydrochlorothiazide recalled over manufacturing violations

Recall date

July 13, 2018

Source

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

Official notice title

Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufact…

Recall number

D-0973-2018

FDA classification

Class II

Brand / firm

Prinston Pharmaceutical Inc

Sold / distributed

United States

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

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09