Drug recall D-0969-2018
Product
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
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots and codes
All lots within expiry.
Recall details
- Recalling firm
- Prinston Pharmaceutical Inc, Cranbury, NJ
- Quantity
- N/A
- Distribution
- United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 13, 2018
Related products
- Valsartan – drug information
- NDC 43547-367 Valsartan · Valsartan 40 mg/1 · Solco Healthcare US, LLC
- NDC 43547-369 Valsartan · Valsartan 160 mg/1 · Solco Healthcare US, LLC
- NDC 43547-370 Valsartan · Valsartan 320 mg/1 · Solco Healthcare US, LLC
- NDC 43547-368 Valsartan · Valsartan 80 mg/1 · Solco Healthcare US, LLC