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Safety Report: Suntegrity Sunscreen foundation - recalled due to higher than acceptable microbiological mold count, USA

1 month ago source fda.gov

Recall notice

United States

On May 24, 2024, Suntegrity Skincare initiated a voluntary recall of nine lots of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) based on its discovery of a higher-than-acceptable microbiological mold count (Species: Aspergillus Sydowii). The product was distributed online by the company and nationwide via retail stores.

A topical product that is found to be contaminated with Aspergillus Sydowii could potentially cause an allergic skin reaction and related symptoms. It could also cause a primary fungal skin infection if used on open wounds or sunburned skin. If it is introduced into the eye, eye infections may occur. A primary skin infection due to Aspergillus species in an immunocompromised individual should be treated medically.

In some tubes of Lot 115BU that developed post-release and over time in a recent test. Out of an abundance of caution, while investigating the situation, the company has decided to voluntarily recall these additional lots: 107IV, 107NU, 109NU, 117BU, 113SA, 114SA, 106BR, and 101MO even though all original and recent test results received have come back clear. The product Lot number can be found on the back side of the tube at the top where the tube is sealed. Visit the below link for a list of all lots and expiration dates.

All Consumers/distributors/retailers that have subject products have been advised to immediately stop use.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Suntegrity Skincare
Brand name: Suntegrity
Product recalled: Sunscreen foundation
Reason of the recall: Higher than acceptable microbiological mold count
FDA Recall date: June 12, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/suntegrity-skincare-issues-voluntary-recall-suntegrity-impeccable-skin-sunscreen-foundation-multiple

#drugs #recall #us

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