RecallDepth
Class II Terminated

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

Company
Indelicare Llc
Recall Initiated
May 23, 2013
Posted
July 3, 2013
Recall Number
D-621-2013
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
683 Bottles
Firm Location
Newbury Park, CA, United States

Reason for Recall

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.

Distribution

California and Colorado.

Lot / Code Info

Lot L0207

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