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Recall Observatory FDA recall evidence

Drug product

Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90

D-1465-2019

June 14, 2019

Class II

Product summary

Firm
Golden State Medical Supply Inc.
Event
Event 83161
Status
Terminated
Classification
Class II
Quantity
32,835 bottles (2,955,150 tablets)
Official record key
drug-enforcement:D-1465-2019

Official wording

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Code information: Lot #: GS017042, Expiration 01/2020; GS017043, Expiration 01/2020; GS017044, Expiration 01/2020; GS017541, Expiration 01/2020

Distribution pattern: US Nationwide One (1) US government account. No foreign accounts.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations