Recalls / Class II
Class IID-0976-2018
Product
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, 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 43547-315-09
- Brand name
- Valsartan And Hydrochlorothiazide
- Generic name
- Valsartan And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Valsartan
- Route
- Oral
- NDCs
- 43547-311, 43547-312, 43547-313, 43547-314, 43547-315
- FDA application
- ANDA206083
- 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-0976-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.