CFSAN Constituent Update
August 7, 2014
- FDA has confirmed bacterial contamination in unopened bottles of inks and on needles included in tattoo kits marketed and distributed by White and Blue Lion, Inc.
- On July 11, 2014, White and Blue Lion, Inc. recalled tattoo inks sold separately and in kits, and tattoo needles in kits. The inks carry a dragon logo on the packaging and are missing the FDA-required name and address of the manufacturer or distributor.
- FDA has received a report of infection associated with the use of the inks that have been recalled and is aware of reports of adverse side effects in others who may have used these or products with similar packaging.
- FDA is concerned that consumers are continuing to use contaminated inks for tattoos. Similarly packaged tattoo products remain available online and may be marketed by other distributors from the same manufacturer. The inks were sold in single units, in sets and in tattoo kits that are marketed for self-tattooing.
- Consumers who purchase tattoo inks or who seek tattooing should examine the ink bottles and determine whether the inks and/or kits are part of the recall. Consumers should not use and should dispose of tattoo inks, tattoo needles and tattoo kits that are recalled or that have similar packaging to those that have been recalled.
What is the Problem?
FDA has confirmed a case of skin infection involving one individual associated with White and Blue Lion tattoo products. The agency is aware of other reports linked to tattoo products with similar packaging.
FDA has tested needles and unopened bottles of these inks and found contamination with multiple strains of bacteria, including Bacillus spp., Acinetobacter spp., Staphylococcus haemolyticus, and Sphingomonas paucimobilis.
FDA is warning consumers not to use tattoo inks and tattoo kits that have been recalled or that have similar packaging to those that have been recalled.
What are the Symptoms of Illness/Injury?
Symptoms of illness include redness, swelling, itching, or blemishes in the tattoo, or pain in the tattoo that does not go away.
FDA has one confirmed case of skin infection that required medical treatment. The agency is aware of other reports linked to tattoo products with similar packaging.
Injecting contaminated ink into the skin or using contaminated needles may result in infections at the site of the tattoo that can spread throughout the body through blood. These infections can be severe and require extensive treatment with antibiotics, hospitalization, or surgery. Sepsis, a potentially life-threatening body-wide infection of the blood, may result. Once the infection has healed, the area may remain permanently scarred.
Who is at Risk?
Anyone receiving a tattoo is at risk for infection, but particularly vulnerable are those with pre-existing heart or circulatory disease, diabetes, or patients with compromised immune systems.
What Do Consumers and Tattoo Artists Need To Do?
Consumers and tattoo artists should be aware of the origin of their materials and should be able to identify and contact the manufacturer in case adverse events occur. Be wary of products that don’t carry a brand or the name and place of business of the manufacturer or distributor. In addition, consumers should take appropriate steps to minimize the possibility that the inks injected into their skin may be contaminated. In this circumstance, the inks have been made from pigments that are not intended for injection into the skin.
If you get a tattoo, monitor the site closely and seek medical care if you notice redness, swelling, itching, or blemishes, or have pain in the tattoo that does not go away.
Adverse events or side effects related to the use of FDA-regulated products should be reported through the MedWatch Safety Information and Adverse Event Reporting Program .
What Do the Products Look Like?
The contaminated inks carry a dragon logo on the packaging and are missing the FDA-required name and address of the manufacturer or distributor. The contaminated inks are sold singly and in sets containing from five to 54 or more bottles of ink of various colors. The contaminated inks are also sold in kits containing needles and tattooing machines.
Some of the sets are intended for permanent makeup, as well as for traditional body tattoos. Containers may be marked with “Lotch” [sic] and Batch numbers, and “Date produced” and “Best if used by” dates.
Where are they Distributed?
The tattoo inks and tattoo kits are sold online and may also be available on secondary reselling sites.
What is FDA doing about the Problem?
FDA is investigating to determine the origin of these inks and will provide more information as it becomes available.
How can I Report a Problem?
Adverse events (negative side effects) related to the use of FDA-regulated products can be reported through the MedWatch Safety Information and Adverse Event Reporting Program by:
- completing and submitting the adverse report online at www.fda.gov/MedWatch/report.htm ;
- downloading the pre-addressed, postage-paid FDA Form 3500 (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178; or
- mailing the completed form to MedWatch, 5600 Fishers Lane, Rockville, MD 20857.
For More Information:
Inks Used in Certain Tattoo Kits Cause Infections
FDA Consumer Advice on Certain Tattoo Inks and Tattoo Kits Sold Online
California Department of Public Health Warns Not to Use Certain Tattoo Products Due to Risk of Infection
Reporting Serious Problems to FDA
Adverse Event Reporting: How to Report a Cosmetic-related Problem to FDA
Bad Reaction to Cosmetics? Tell FDA
Think Before You Ink: Are Tattoos Safe?