Recalls / Class II
Class IID-0209-2018
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.
- Brand name
- Valsartan
- Generic name
- Valsartan
- Active ingredient
- Valsartan
- Route
- Oral
- NDCs
- 43547-367, 43547-368, 43547-369, 43547-370
- FDA application
- ANDA204821
- Affected lot / code info
- Lot #: 343B17025, Exp 03/31/19
Why it was recalled
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Recalling firm
- Firm
- Prinston Pharmaceutical Inc
- Manufacturer
- Solco Healthcare US, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2002 Eastpark Blvd, N/A, Cranbury, New Jersey 08512-3514
Distribution
- Quantity
- 21,987 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-11-29
- FDA classified
- 2018-01-08
- Posted by FDA
- 2018-01-17
- Terminated
- 2019-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0209-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.