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Recall Observatory FDA recall evidence

Drug 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

D-1049-2019

March 01, 2019

Class II

Product summary

Firm
Legacy Pharmaceutical Packaging LLC
Event
Event 82326
Status
Ongoing
Classification
Class II
Quantity
2,851,284 bottles
Official record key
drug-enforcement:D-1049-2019

Official wording

Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

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

Distribution pattern: Wal-Mart distribution centers in AR, CA, GA, IN and MD

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    impurity, N-Methylnitrosobutyric acid (NMBA
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations

Field note

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