FDAFDA · Food and drugs·Recall number D-1132-2018
Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Published September 5, 2018 · Recall initiated: August 14, 2018
Status when published: Terminated — 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
- Manufacturer
- AVKARE Inc.
- Distributor
- U.S. Nationwide
- Lot
- Lots: 17717 Exp. 07/2018; 18493 Exp. 01/2019; 19761 Exp. 04/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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