Class II
Ongoing
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
This recall is currently active, issued March 27, 2019. It was issued by Legacy Pharmaceutical Packaging Llc.
- Recall Initiated
- March 1, 2019
- Posted
- March 27, 2019
- Recall Number
- D-1049-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,851,284 bottles
- Firm Location
- Earth City, MO, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Distribution
Wal-Mart distribution centers in AR, CA, GA, IN and MD
Lot / Code Info
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
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