FDA Warns About Tattoo Risks after Two Recalls of Contaminated Tattoo InksAug 13, 2015
The Food and Drug Administration (FDA) is warning consumers about infection risks in connection with the recent recall of contaminated tattoo inks.
On August 4, A Thousand Virgins Corp. of Miami, Florida, recalled grey wash tattoo inks G1, G2 and G3, labeled Lot #129, expiration date 1/16. The recall was undertaken were because of microbiological contamination of the inks. Full details of the recall can be found on the FDA web site.
FDA laboratory testing found microbial contamination in the inks. The inks are contaminated with Mycobacterium chelonaeorganisms and the molds Cryptococcus albidus and members of thePenicillium genus. The FDA warns that use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection.
The grey inks from A Thousand Virgins were distributed nationwide in individual bottles and in kits. They may also be available through international and online distributors. Despite the recall, the FDA is concerned that artists and consumers are continuing to use these contaminated inks from their current stock.
No one should use any of the recalled tattoo inks. Artists and consumers who purchase tattoo inks and anyone seeking tattooing should carefully check the ink bottles to see if they are included in the recall. Anyone who finds inks under recall should carefully place the closed bottles of ink into a plastic bag, sealing or tying off the bag to prevent leakage. The first bag should be put in a second bag, also tied off or sealed. Before disposing of contaminated inks, consult local waste management authorities for requirements for proper disposal.
Consumers with questions about tattoo inks may contact A Thousand Virgins at 1-866-829-4659 from Monday to Friday between the hours of 9 a.m. to 5 p.m. EST.
Linda Katz, M.D., M.P.H., director of the FDA’s Office of Cosmetics and Colors, says contaminated tattoo inks could cause infection. “Tattooing poses a risk of infection to anyone,” Katz warns, “but the risk is particularly high for those with pre-existing heart or circulatory disease, diabetes or compromised immune systems.” Katz explains that injecting contaminated ink into the skin or using contaminated needles may result in infections at the site of the tattoo. Redness, swelling, weeping wounds, blemishes, or excessive pain at the site are signs of infection. Anyone who experiences signs of infection should seek immediate medical care. Even after a localized infection has healed, the FDA says, the area may be permanently scarred. If an infection is left untreated or is inadequately treated, it could spread through the bloodstream (a process known as sepsis).
Consumers and tattoo artists are encouraged to report adverse events through the MedWatch Safety Information and Adverse Event Reporting Program so that the FDA can investigate and prevent others from being infected.