FDA-Drug2018-01-17Class II

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.

Prinston Pharmaceutical Inc
Hazard

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

Sold states
Nationwide in the USA and Puerto Rico
Affected count
21,987 bottles
Manufactured in
2002 Eastpark Blvd, N/A, Cranbury, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0209-2018

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