The Recall Desk

FDA (Drugs) recall action 65284

Indelicare LLC recalled 2 products on 2013-07-03

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-07-03
Critical
0
Units
3,532

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2013-07-03

    INK-EEZE Tattoo Numbing Spray Recalled for Lack of FDA Approval

    Indelicare LLC is recalling INK-EEZE Tattoo Numbing Spray because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    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.
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2013-07-03

    FDA Recalls Ink-Eeze Tattoo Numbing Spray for Lack of Approval

    Indelicare LLC is recalling Ink-Eeze Tattoo Numbing Spray because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    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
    Category
    Distribution
    2 states