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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