The Recall Desk
ModerateFDA (Drugs)·D-622-2013·Announced 2013-07-03

INK-EEZE Tattoo Numbing Spray Recalled for Lack of FDA Approval

Indelicare LLC is recalling INK-EEZE Tattoo Numbing Spray because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

What this means for you

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: The recall is classified as FDA Class II, which typically involves a risk of temporary or medically reversible adverse health consequences. The primary hazard is the lack of regulatory approval rather than a specific reported injury or contamination event.

Plain-English summary

Indelicare LLC is recalling INK-EEZE Tattoo Black Label Numbing Spray, a topical anesthetic containing 5% Lidocaine HCl. The recall involves 2,849 bottles in two sizes: 0.27 oz (8 mL) and 2 oz (59 mL). The specific lot number is L0211.

The FDA issued this recall because the product is being marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Although Lidocaine 5% is an ingredient in many FDA-approved products, the specific INK-EEZE formulation is considered an unapproved new drug.

The product was distributed in California and Colorado. Consumers who purchased this product should stop using it and contact Indelicare LLC for further instructions.

The recalled product

Product
INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com.
Manufacturer
Indelicare LLC
Category
Drug — Topical Anesthetic
Hazard
Affected units
2,849

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 (1)

  • Lot #: L0211

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Indelicare 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.

See all 2 products in this recall →

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