Drug product
Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-579-54
D-1050-2019
Product summary
- Event
- Event 82326
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,497,856 bottles
- Official record key
drug-enforcement:D-1050-2019
Official wording
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Code information: 180886, Nov-19; 180887, 180888, 180905, Dec-19; 181123, Sep-2019; 181124, Oct-2019, 181125, Aug-19, 181351, Nov-19, 181352, Dec-19, 181551, Nov-19, 181628, 181629, 181727, 181728, Jun-20; 181890, Mar-20; 181891, 181897, Jun-20; 182114, Mar-20; 182119, 182120, Jun-20
Distribution pattern: Wal-Mart distribution centers in AR, CA, GA, IN and MD
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-Methylnitrosobutyric acid (NMBA
-
Manufacturing or process control
CGMP Deviations