Drug product
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11
D-0302-2026
Product summary
- Event
- Event 98361
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0302-2026
Official wording
Reason: cGMP deviations
Code information: Lot Numbers J01 through J14, J55 through J69
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
cGMP deviations