Recall: D-0976-2018

Class II - Potentially Harmful

Class IIClassification

2018-07-13Initiated

OngoingStatus

Prinston Pharmaceutical IncFirm

Product

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 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 43547-315-09

Reason

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution

United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.