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Recall Observatory FDA recall evidence

Drug product

Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ

D-1281-2019

April 30, 2019

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc
Event
Event 82791
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-1281-2019

Official wording

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Code information: a) 30 tablets: lot A1818G batch 01181807 exp 3/2020; b) 90 tablets: lot L0517L batch 12051712 exp 3/2020

Distribution pattern: CA, GA, IN. No DOD/VA accounts. No foreign accounts.

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