FDA-Drug2018-08-01Class II
Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, 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 43547-368-09
Prinston Pharmaceutical Inc
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
United States
Affected count
N/A
Manufactured in
2002 Eastpark Blvd, N/A, Cranbury, NJ, United States
Products
Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, 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 43547-368-09
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0969-2018Don't want to check this manually?
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