D-0209-2018 Class II Terminated
FDA drug recall D-0209-2018 was initiated by Prinston Pharmaceutical Inc on Nov 29, 2017 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle. The recall status is terminated (terminated Aug 16, 2019). Affected quantity: 21,987 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 17, 2018
- Initiation Date
- Nov 29, 2017
- Termination Date
- Aug 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,987 bottles
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #: 343B17025, Exp 03/31/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0209-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026