Drug 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.
D-0209-2018
Product summary
- Event
- Event 78651
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,987 bottles
- Official record key
drug-enforcement:D-0209-2018
Official wording
Reason: Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Code information: Lot #: 343B17025, Exp 03/31/19
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.