FDAFDA · Food and drugs·Recall number D-0976-2018
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
Published August 1, 2018 · Recall initiated: July 13, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VALSARTAN AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Prinston Pharmaceutical Inc
- Distributor
- United States
- UPC
- 0343547315092
- Lot
- All lots within expiry.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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