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Recall Observatory FDA recall evidence

Drug product

Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

D-0288-2024

January 19, 2024

Class II

Product summary

Firm
OMEZA LLC
Event
Event 93847
Status
Terminated
Classification
Class II
Quantity
4390 vials
Official record key
drug-enforcement:D-0288-2024

Official wording

Reason: CGMP Deviations

Code information: Lots: 28622 2-1, Exp. 04/24/2024 286222-3, Exp. 1/25/2024 or 04/25/2024

Distribution pattern: US Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations