Class II
Ongoing
Solco Healthcare US Valsartan, USP, 320 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 43547-370-09
This recall is currently active, issued August 1, 2018. It was issued by Prinston Pharmaceutical Inc.
- Company
- Prinston Pharmaceutical Inc
- Recall Initiated
- July 13, 2018
- Posted
- August 1, 2018
- Recall Number
- D-0971-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Cranbury, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
United States
Lot / Code Info
All lots within expiry.
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