drugs Class II Updated 2013-07-03

Indelicare LLC recalls INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: California and Colorado.
Lot/Code Info: Lot #: L0211
View official government recall

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