Tattoo numbing spray recalled over manufacturing practice deviations
Pro Numb Tattoo Numbing Spray LLC is recalling Pro Numb Tattoo Numbing Spray, 5% Lidocaine, over cGMP deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a precautionary recall: the record cites generic cGMP deviations with no named contaminant, defect or reported harm.
Plain-English summary
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, in 1 FL OZ (28.4 mL) and 4 oz (120 mL) bottles, distributed by Pro Numb Tattoo Numbing Spray LLC of Melbourne, Florida, under NDC 83389-111-11, is being recalled.
The reason given in the enforcement record is cGMP deviations.
The record's quantity field reads 'N/A'. The recall covers lot numbers J01 through J14 and J55 through J69. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record cites manufacturing practice deviations without naming a specific defect or contaminant, and reports no injuries. Consumers should follow the seller's return instructions.
The recalled product
- Product
- PRO NUMB (TATTOO NUMBING SPRAY)
- Brand
- PRO NUMB
- Manufacturer
- Pro Numb Tattoo Numbing Spray LLC
- Category
- Drug — Topical anesthetic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers J01 through J14
- J55 through J69
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pro Numb Tattoo Numbing Spray LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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