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Recall Observatory FDA recall evidence

Drug product

Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials

D-0289-2024

January 19, 2024

Class II

Product summary

Firm
OMEZA LLC
Event
Event 93847
Status
Terminated
Classification
Class II
Quantity
1210 vials
Official record key
drug-enforcement:D-0289-2024

Official wording

Reason: CGMP Deviations

Code information: Lot: 19123 4-1, Exp. 05/11/2024

Distribution pattern: US Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations