Recall Enforment Report D-1049-2019
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Legacy Pharmaceutical Packaging LLC, originally initiated on 03-01-2019 for the product Losartan Potassium Tablets, USP, 50 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 68645-578-54 The product was recalled due to cgmp deviations: presence of an impurity, n-methylnitrosobutyric acid (nmba) detected. The product was distributed in Wal-mart Distribution Centers In Ar, Ca, Ga, In And Md and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1049-2019 | 03-01-2019 | 03-27-2019 | Class II | 2,851,284 bottles | Losartan Potassium Tablets, USP, 50 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 68645-578-54 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Ongoing |
| D-1048-2019 | 03-01-2019 | 03-27-2019 | Class II | 456,732 bottles | Losartan Potassium Tablets, USP, 25 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 68645-577-54 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Ongoing |
| D-1050-2019 | 03-01-2019 | 03-27-2019 | Class II | 2,497,856 bottles | 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 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Ongoing |
