FDAFDA · Food and drugs·Recall number D-1133-2018
Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 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: 17718 Exp. 07/2018; 18700 Exp. 01/2019; 19133 Exp. 02/2019; 19532 Exp. 04/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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