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.

FDA recall notice · announced January 17, 2018 · Prinston Pharmaceutical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot #: 343B17025, Exp 03/31/19
Quantity: 21,987 bottles
Status: Terminated
Products in this recall event:
- 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, (D-0209-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.