The FDA is concerned that consumers may be continuing to use contaminated inks for tattoos. FDA became aware of a problem after testing inks and needles included in tattoo kits marketed by White and Blue Lion, Inc. White and Blue Lion recalled these contaminated products on July 11, 2014, but the FDA is concerned that consumers may have purchased such products from other distributors.
The inks in question may be identified by a dragon logo on the packaging and the lack of the name and address of the manufacturer. FDA regulations require that the manufacturers name and address appear on the product label. The inks were sold in multiple forms: as single units, in sets, and in tattoo kits.
Using these inks for tattoos could cause infection. The FDA has confirmed one case of skin infection involving an individual that used White and Blue Lion tattoo products. The agency is aware of other reports linked to tattoo products with similar packaging.
The FDA is warning consumers not to use tattoo inks and tattoo kits that are part of the recall or that are missing essential information, such as the name and place of business of the manufacturer or distributor.
The inks are sold singly and in kits containing anywhere from five to 54, or perhaps more, bottles of ink of various colors. Some of the inks 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.
Consumers who purchase tattoo inks or who seek tattooing should examine the ink bottles and determine whether the inks and/or kits meet this description.
Who Should Know
All consumers and tattoo artists should avoid using contaminated products. Although tattooing presents potential risk of infection to anyone, particularly those with pre-existing heart or circulatory disease, diabetes or compromised immune systems, contaminated tattoo products put people at greater risk of infection.
What to Do
- The FDA advises consumers and tattoo artists to avoid using tattoo inks and tattoo kits that have no brand name, carry a dragon logo, and are missing the name and place of business of the manufacturer or distributor.
- If you recently got a tattoo, body art or permanent make-up and are experiencing redness, swelling, weeping wounds, blemishes or excessive pain at the site, seek medical care right away.
- You can report adverse events or side effects related to the use of FDA-regulated products 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.
Why This Advice is Important
The FDA has tested samples of these tattoo inks and tattoo kits and found them to contain dangerous bacteria that can cause serious infections. These infections can be severe and require treatment with antibiotics, hospitalization, and surgery. Sepsis, a potentially life-threatening, body-wide infection of the blood, may occur as a result. The area, once healed, may remain permanently scarred.
For more information see
- Consumer Update: Inks Used in Certain Tattoo Kits Cause Infection
- Constituent Update: FDA Warns Consumers Not to Use Certain Tattoo Inks and Tattoo Kits Sold Online