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Recall Observatory FDA recall evidence

Drug product

Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54

D-1075-2019

March 01, 2019

Class II

Product summary

Firm
Legacy Pharmaceutical Packaging LLC
Event
Event 82490
Status
Terminated
Classification
Class II
Quantity
179,544 30-count bottles
Official record key
drug-enforcement:D-1075-2019

Official wording

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

Code information: Lots: 180190, 180191 (exp 10/2020) and 181597 (exp 02/2021)

Distribution pattern: AZ, IN, TN

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