Pro Numb Tattoo Numbing Spray Recalled Due to Manufacturing Deviations
Pro Numb Tattoo Numbing Spray LLC has issued a voluntary recall for specific lots of its 5% Lidocaine spray due to Current Good Manufacturing Practice (cGMP) deviations.
What Happened
Pro Numb Tattoo Numbing Spray LLC has initiated a voluntary recall of its Pro Numb Tattoo Numbing Spray. The recall was triggered by Current Good Manufacturing Practice (cGMP) deviations. These deviations indicate that the products may not have been manufactured under conditions that ensure their safety, quality, and purity according to federal standards.
Which Products Are Affected
The recall affects the following products distributed nationwide in the United States:
- Product Name: Pro Numb Tattoo Numbing Spray (5% Lidocaine)
- Sizes: 1 FL OZ (28.4 ML) and 4 oz (120 mL) bottles
- NDC Number: 83389-111-11
- Lot Numbers: J01 through J14 and J55 through J69
- Manufacturer: Pro Numb Tattoo Numbing Spray LLC, Melbourne, FL
What You Should Do
Consumers who possess the affected lot numbers should immediately discontinue use of the product. The firm initiated the recall notification via letter on February 2, 2026. Consumers may contact the recalling firm, Pro Numb Tattoo Numbing Spray LLC, at their Palm Bay, Florida location for further instructions regarding the return or disposal of the affected units.
Why This Matters
Adherence to cGMP regulations is critical for ensuring that over-the-counter drugs meet safety and efficacy standards. Deviations from these practices can lead to inconsistencies in the product’s strength or potential contamination, posing a risk to consumers using the spray for topical numbing.
Source
This information is based on official recall data provided by the FDA under recall number D-0302-2026.
Source: FDA Official Notice
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