Why it was recalled
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.
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, www.inkeeze.com.
Lot numbers, UPCs & expiration codes
Lot #: L0211
Where it was sold
California and Colorado.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-622-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 23, 2013
- FDA report date
- Jul 3, 2013
- Quantity
- 2849 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Indelicare LLC
Original FDA data
Every field from FDA enforcement report D-622-2013, exactly as published.
Show all FDA fields
- City
- Newbury Park
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 65284
- Address
- 914 Tourmaline Drive
- Code information
- Lot #: L0211
- Postal code
- 91320
- Report date
- Jul 3, 2013
- Product type
- Drugs
- Recall number
- D-622-2013
- Classification
- Class II
- Recalling firm
- Indelicare LLC
- Product quantity
- 2849 Bottles
- Termination date
- Jun 30, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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, www.inkeeze.com.
- Distribution pattern
- California and Colorado.
- Recall initiation date
- May 23, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 27, 2013