FDA recall D-622-2013

Indelicare LLC · Class II · drug

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.

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.

Key facts

Status: Terminated
Initiation date: 2013-05-23
Report date: 2013-07-03
Termination date: 2014-06-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Newbury Park, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-622-2013