Drug recall D-0209-2018
Product
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.
Reason for recall
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Lots and codes
Lot #: 343B17025, Exp 03/31/19
Recall details
- Recalling firm
- Prinston Pharmaceutical Inc, Cranbury, NJ
- Quantity
- 21,987 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 29, 2017
- Terminated
- August 16, 2019
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