D-1050-2019 Class II Ongoing
FDA drug recall D-1050-2019 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: 2,497,856 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 27, 2019
- Initiation Date
- Mar 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,497,856 bottles
Product Description
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
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
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1050-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026