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07-06-2013, 01:43 AM #1
- Join Date
- Aug 2012
- Merced, CA 95348-1422
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Recall: INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz...
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 Id 65284
Product Type Drugs
City Newbury Park
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern California and Colorado.
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