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Recall Observatory FDA recall evidence

Drug product

Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11

D-0303-2026

February 02, 2026

Class II

Product summary

Firm
Pro Numb Tattoo Numbing Spray LLC
Event
Event 98361
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0303-2026

Official wording

Reason: cGMP deviations

Code information: Lot Number J15

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations