PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: January 17, 2018 Initiated: November 29, 2017 #D-0209-2018

Product Description

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.

Details

Units Affected
21,987 bottles
Distribution
Nationwide in the USA and Puerto Rico
Location
Cranbury, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Prinston Pharmaceutical Inc. Units affected: 21,987 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 17, 2018. Severity: Moderate. Recall number: D-0209-2018.