Class II
Terminated
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- Company
- Avkare Inc.
- Recall Initiated
- August 14, 2018
- Posted
- September 5, 2018
- Recall Number
- D-1130-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6776 cartons (338,800 tablets)
- Firm Location
- Pulaski, TN, United States
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
U.S. Nationwide
Lot / Code Info
Lots: 18491 Exp. 10/2018; 19531 Exp. 04/2019; 20168 Exp. 05/2019; 20671 Exp. 08/2019; 21049 Exp. 10/2019; 21635 Exp. 10/2019
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