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Recall Observatory FDA recall evidence

Drug 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

D-621-2013

May 23, 2013

Class II

Product summary

Firm
Indelicare LLC
Event
Event 65284
Status
Terminated
Classification
Class II
Quantity
683 Bottles
Official record key
drug-enforcement:D-621-2013

Official wording

Reason: Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.

Code information: Lot L0207

Distribution pattern: California and Colorado.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.