Status
Terminated
Drug Enforcement D-621-2013
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.
Classification
Class II
Report Date
July 3, 2013
Termination Date
June 30, 2014
Product Information
- Product description
- 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
- Product quantity
- 683 Bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- California and Colorado.
Location & Firm
- Recalling firm
- Indelicare LLC
- Address
-
914 Tourmaline Drive
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-621-2013
- Event ID
- 65284
- Recall initiation date
- May 23, 2013
- Center classification date
- June 27, 2013
- Code info
- Lot L0207
- More code info
- —