Product: 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
Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: 20180713
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated