Drug product
Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
D-1044-2019
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 82314
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1044-2019
Official wording
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Code information: Lots: 20961 Exp. 09/2019; 20477 Exp. 08/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-Methylnitrosobutyric acid (NMBA
-
Manufacturing or process control
CGMP Deviations