Recall: D-0209-2018

Class II - Potentially Harmful

Class IIClassification

2017-11-29Initiated

TerminatedStatus

Prinston Pharmaceutical IncFirm

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

Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.

Distribution

Nationwide in the USA and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.