Recalls / Class II
Class IID-0969-2018
Product
Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09
- 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
- All lots within expiry.
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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
- N/A
- Distribution pattern
- United States
Timeline
- Recall initiated
- 2018-07-13
- FDA classified
- 2018-07-20
- Posted by FDA
- 2018-08-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0969-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.