FDA Recalls Ink-Eeze Tattoo Numbing Spray for Lack of 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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The primary issue is regulatory (unapproved status) rather than a reported safety incident or high-risk pathogen.
Plain-English summary
Indelicare LLC is voluntarily recalling 683 bottles of Ink-Eeze Tattoo Numbing Spray, 2 oz. (59 mL). The product contains 5% Lidocaine HCl as a topical anesthetic and was distributed in California and Colorado. The specific lot number is L0207.
The recall was initiated 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 formulation in Ink-Eeze is considered an unapproved new drug.
Consumers who have purchased this product should stop using it and contact Indelicare LLC at (800) 611-7720 or visit www.inkeeze.com for further instructions.
The recalled product
- Product
- INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), 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
- 683
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 L0207
Distribution
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 →Related recalls
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FDA (Drugs) · 2013-07-03
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