Recalls, Market Withdrawals, & Safety Alerts

Latest Recall - October 4, 2019

Florida Department of Health Warns Tattoo Artists and their Clientele of Contaminated Tattoo Inks

The Florida Department of Health (FDOH) would like to make tattoo artists and their clientele aware of the U.S. Food and Drug Administration’s (FDA) recent findings about two specific tattoo ink brands Intenze Product Inc. and Color Art, Inc. DBA Solid Ink. The FDA reports the inks as adulterated and misbranded cosmetics due to:

• Microbial contamination in tattoo inks that are on the market.
• Tattoo inks that are on the market being prepared, packed, or held under insanitary conditions.
• Labeling of the tattoo inks on the market being false or misleading because the products are labeled as “sterile” but were found to contain microorganisms.

Tattoo inks contaminated with micro-organisms can cause infections and lead to serious health injuries when injected into the skin during a tattooing procedure, since there is an increased risk of infection any time the skin barrier is broken.

Products 

The tattoo inks referred in the warning letters are: 

• Intenze Advanced Tattoo Ink - True Black
• Intenze - Raw Umber Light
• Solid Ink - Super Red
• Solid Ink - Matte Black
• Solid Ink - White
• Solid Ink - Yellow
• Solid Ink - Orange
• Solid Ink - Olive
• Solid Ink - Deep Red
• Solid Ink – Diablo

The warning letters may be found here: 

• Intenze Product Inc. Warning Letter
• Color Art, Inc. DBA Solid Ink Warning Letter

May 15, 2019

FDA Advises Consumers, Tattoo Artists, and Retailers to Avoid Using or Selling Certain Tattoo Inks Contaminated with Microorganisms

The FDA is alerting consumers, tattoo artists, and retailers of the potential for serious injury from use of tattoo inks that are contaminated with bacteria. Tattoo inks contaminated with microorganisms can cause infections and lead to serious health injuries when injected into the skin during a tattooing procedure, since there is an increased risk of infection any time the skin barrier is broken.

Commonly reported symptoms of tattoo-ink-associated infections include the appearance of rashes or lesions consisting of red papules in areas where the contaminated ink has been applied. Some tattoo infections can result in permanent scarring. Indications of an infection can be difficult to recognize as other conditions (e.g., allergic reactions) may initially have similar signs and symptoms, leading to misdiagnosis and ineffective treatments.

 Products

The following tattoo inks have been recalled because they are contaminated with microorganisms:

 Scalpaink SC, Scalpaink PA, andand Scalpaink ALbasic black tattoo inks manufactured by Scalp Aesthetics (all lots)

• Dynamic Color - Black tattoo ink manufactured by Dynamic Color Inc (lots 12024090 and12026090)
• Solid Ink - Diablo (red) tattoo ink manufactured by Color Art Inc. (dba Solid Ink) (dba Antone's Ink) (lot 10.19.18)

 Read the full update

March 27, 2018

Recently recalls made by Fusion Tattoo Ink and by the Food and Drug Administration (FDA) recalled certain tattoo inks due to microbial contamination.  The inks are made by Fusion Tattoo Ink and are  currently listed on the the FDA's website, including Royal Blue Glycerin, Pretty Purple, and Gamma Green, indicating the shade.

Artists and consumers who purchase tattoo inks or who seek tattooing should examine the ink bottles and determine whether the product is part of the recall. Artists and consumers should not use and should dispose of tattoo inks that have been recalled.

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. Clients should monitor the tattoo site closely and seek medical care if they notice redness, swelling, itching, bumps or blemishes, or have pain in the area of the tattoo that does not go away. Tattoo establishment owners and artists should refer any client noticing these symptoms to seek medical care as well.

Florida tattoo establishment owners and artists should report knowledge of any client or cluster of clients with ink-related adverse side effects to the local county health department having jurisdiction of the tattooing program.

For details on the recalls listed above,

1. Please visit Enforcement Reports
2. Select “Advanced Search”
3. Enter the company name under “Recalling Firm”
4. Select “Search”

August 14, 2015

Recalls made by A Thousand Virgins, Inc. and by the U.S. Food and Drug Administration recalled certain tattoo inks sold separately and in sets. The inks are made by A Thousand Virgins, Inc. and are labeled “G1,” “G2” and “G3,” indicating the shade, and “Lot #129 Exp. 1/16.” Unopened inks, manufactured in Florida and collected during the investigation, were found to contain harmful microorganisms, including Mycobacterium chelonae.

Artists and consumers who purchase tattoo inks or who seek tattooing should examine the ink bottles and determine whether the product is part of the recall. Artists and consumers should not use and should dispose of tattoo inks that have been recalled. 

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. Clients should monitor the tattoo site closely and seek medical care if they notice redness, swelling, itching, bumps or blemishes, or have pain in the area of the tattoo that does not go away. Tattoo establishment owners and artists should refer any client noticing these symptoms to seek medical care as well.

Florida tattoo establishment owners and artists should report knowledge of any client or cluster of clients with ink-related adverse side effects to the local county health department having jurisdiction of the tattooing program.

Mycobacterium chelonae is commonly present in tap water and is not reliably removed by filtration or by boiling for short periods. The Centers for Disease Control and Prevention (CDC) and the FDA recommend tattoo artists avoid contamination of ink by only using single use sterile water products for dilution of inks and washes as tap water, distilled water, filtered water, reverse osmosis water, or other non-sterile water has the potential to be contaminated.