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Recall Observatory FDA recall evidence

Drug product

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

D-1050-2019

March 01, 2019

Class II

Product summary

Firm
Legacy Pharmaceutical Packaging LLC
Event
Event 82326
Status
Ongoing
Classification
Class II
Quantity
2,497,856 bottles
Official record key
drug-enforcement:D-1050-2019

Official wording

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

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

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