D-622-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 3, 2013
- Initiation Date
- May 23, 2013
- Termination Date
- June 30, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2849 Bottles
Product Description
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 Pattern
California and Colorado.
Code Information
Lot #: L0211