Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufacture
Recalled August 1, 2018 · FDA recall D-0976-2018 · Prinston Pharmaceutical
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
N/A
Sold at
United States
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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
Manufacturer(s)
Prinston Pharmaceutical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →