# FDA recall D-622-2013

> **Indelicare LLC** · Class II · drug recall initiated 2013-05-23.

## 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.

## Distribution

California and Colorado.

## Key facts

- **Recall number:** D-622-2013
- **Recalling firm:** Indelicare LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-23
- **Report date:** 2013-07-03
- **Termination date:** 2014-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newbury Park, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-622-2013

## Citation

> AI Analytics. FDA recall D-622-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-622-2013. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*