FDA recalls certain tattoo inks

Inks affected are from A Thousand Virgins in grey wash shades

WASHINGTON, D.C. – The Food and Drug Administration is recalling certain tattoo inks marketed and distributed by A Thousand Virgins.

The inks affected are in grey wash shades labeled G1, G2 and G3 (Lot #129 exp 1/16).

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The FDA found bacterial contamination, including Mycobacterium chelonae, in unopened bottles of these tattoo inks.

The FDA tested the inks to assist the Florida Department of Health in its investigation of an outbreak of mycobacterial infections in people who recently got tattoos.

A Thousand Virgins recalled certain tattoo inks on August 4 sold separately and in sets, but the FDA is concerned artists and consumers are continuing to use these contaminated inks from their current stock.

Tattoo products with the same lot number manufactured by A Thousand Virgins may still be available online and may be marketed by other distributors. 

What are the symptoms of illness/injury?

When contaminated tattoo ink is injected into the skin, the bacteria can cause an infection that remains at the site or may spread throughout the body. The infection may results in redness; swelling; itching; raised pink, red or purple blemishes in the tattoo; or pain int he tattoo that does not go away.  

If you have these symptoms, seek medical treatment. You may also notice swollen and tender lymph nodes.

These infections can be severe and may require extensive treatment with antibiotics, hospitalization, or surgery. Sepsis, a potentially life-threatening body-wide infection of the blood, has been reported in cases of injection of contaminated tattoo inks. Once the infection has healed, the area may remain permanently scarred.

What to do if you have recalled tattoo ink

If you find inks subject to recall, place the closed bottles of ink into a plastic bag, sealing or tying off the bag to prevent leakage.

Put this first bag into a second bag and tie off the second bag separately. 

Check with your local waste management authorities for any disposal requirements in effect for your area.

People with infected tattoos and tattoo artists whose clients notify them of potentially infected tattoos can report adverse events or side effects through the MedWatch Safety Information and Adverse Event Reporting Program.


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