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  1. Cosmetics Compliance & Enforcement

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

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

This Safety Alert was updated on May 21. It was originally published on May 17. 

Audience

  • Consumers who are considering a new tattoo
  • Tattoo artists
  • Retailers of tattoo inks

Product

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

  • Scalpaink SC, Scalpaink PA, and Scalpaink AL basic black tattoo inks manufactured by Scalp Aesthetics (all lots distributed from 8/6/2018 through 10/1/2018) – Recall Completion Date 5/17/2019
  • Dynamic Color - Black tattoo ink manufactured by Dynamic Color Inc  (lots 12024090 and 12026090)
  • Solid Ink-Diablo (red) tattoo ink manufactured by Color Art Inc. (dba Solid Ink) (dba Antone's Ink) (lot 10.19.18)

Purpose

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.

Summary of Problem and Scope

The FDA has become aware of contaminated tattoo inks through its FY2018-2019 inspections of distributors and manufacturers, routine surveys of marketed tattoo inks, and subsequent microbiological analysis of sampled tattoo inks. The FDA has identified 6 tattoo inks contaminated with bacteria harmful to human health and is working with the manufacturers/distributors to remove all contaminated product from the market. The tattoo inks were manufactured or distributed by 4 firms inspected under an ongoing assignment. Tattoo inks were analyzed using methods described in the Bacteriological Analytical Manual Chapter 23: Microbiological Methods for Cosmetics, which is the general method used to determine bacterial contamination of cosmetics.

Recommendations for Consumers

Ask the tattoo artist or studio about the tattoo inks they use and avoid the recalled tattoo inks listed above, due to risk of infection and injury.

Recommendations for Tattoo Artists, and Retailers

Avoid using or selling the recalled tattoo inks mentioned above, due to risk of infection and injury.

FDA Actions

The FDA will continue to work with manufacturers and retailers to remove contaminated products from the market.

Reporting Problems to the FDA

Consumers who have experienced symptoms of infection or an injury after administration of a tattoo should consult their healthcare professional and inform their tattoo artist. Consumers should also consider reporting their injury to MedWatch: FDA’s Safety Information and Adverse Event Reporting Program. The FDA encourages consumers with questions about product safety to submit an inquiry, or to visit www.fda.gov/fcic for additional information.


Scalpaink SC, Scalpaink PA, and Scalpaink AL Basic Black Tattoo Inks (manufactured by Scalp Aesthetics)

Scalpaink SC, Scalpaink PA, and Scalpaink AL Basic Black Tattoo Inks (manufactured by Scalp Aesthetics)

Dynamic Color - Black Tattoo Ink (manufactured by Dynamic Color Inc)

Dynamic Color - Black Tattoo Ink (manufactured by Dynamic Color Inc)

Solid Ink-Diablo (red) Tattoo Ink (manufactured by Color Art Inc.)

Solid Ink-Diablo (red) Tattoo Ink (manufactured by Color Art Inc.)

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