Product Detail

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, Home - Inkeeze - Tattoo Lifestyle Products - Tattoo Pain Relief, Tattoo Healing, and Tattoo Aftercare.

Recall Number D-622-2013

Classification Class II

Code Info Lot #: L0211

Product Distributed Qty 2849 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.

Event Detail

Event Id 65284

Product Type Drugs

Status Ongoing

Recalling Firm
Indelicare LLC
City Newbury Park

State CA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-05-23

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern California and Colorado.