D-1049-2019 Class II Ongoing
FDA drug recall D-1049-2019 was initiated by Legacy Pharmaceutical Packaging LLC on Mar 1, 2019 and is designated Class II. Reason for recall: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected The recall status is ongoing. Affected quantity: 2,851,284 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 27, 2019
- Initiation Date
- Mar 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,851,284 bottles
Product Description
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
Reason for Recall
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Distribution Pattern
Wal-Mart distribution centers in AR, CA, GA, IN and MD
Code Information
Lots: 180921, exp Sep-19, 180922, exp Oct-19, 180923, 180924, 181118, exp Nov-19, 181119, exp Oct-19, 181407, exp Nov-19, 181408, exp Dec-19, 181573, 181725, 181726, exp Feb-20, 181948, exp Mar-20, 181960, exp Feb-20, 182385, 182386, 182387, exp Mar-20
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1049-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026