Drug recall D-0976-2018
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
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 and Hydrochlorothiazide – drug information
- NDC 43547-311 Valsartan And Hydrochlorothiazide · Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 · Solco Healthcare US, LLC
- NDC 43547-312 Valsartan And Hydrochlorothiazide · Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 · Solco Healthcare US, LLC
- NDC 43547-315 Valsartan And Hydrochlorothiazide · Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 · Solco Healthcare US, LLC
- NDC 43547-314 Valsartan And Hydrochlorothiazide · Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 · Solco Healthcare US, LLC
- NDC 43547-313 Valsartan And Hydrochlorothiazide · Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 · Solco Healthcare US, LLC