FDAFDA · Food and drugs·Recall number D-621-2013
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
Published July 3, 2013 · Recall initiated: May 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Indelicare LLC
- Distributor
- California and Colorado.
- Lot
- Lot L0207
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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