Indelicare LLC Recall: INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2
Indelicare LLC Recall: INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Indelicare LLC; Product: INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidoc
| Recalling firm | Indelicare LLC |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | California and Colorado. |
| Recall initiated | 20130523 |
| Recall number | D-622-2013 |
| Category | drug |
| State | CA |
| Country | United States |
$29/mo
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