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Safety Report: TING® 1% Tolnaftate Athlete’s Foot Spray recalled due to Benzene presence, USA

4 months ago source fda.gov

Recall notice

United States

Insight Pharmaceuticals is voluntarily recalling two lots of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid to the consumer level due to elevated levels of benzene. The affected TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid lots were distributed nationwide in the United States through a limited number of retailers and online. No serious adverse events have been reported to date.

TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid is packaged in blue and white aerosol cans with Lot codes located on the bottom of the can. Samples of the recalled lots below have been found to contain elevated levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Ting products.

- Product: TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid, NDC: 63736-819-05, Lot Number: 0H50545, Expiration Date: 07/24, Package Size: 4.5 oz/128 g.
- Product: TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid, NDC: 63736-819-05, Lot Number: 1G50645, Expiration Date: 06/25, Package Size: 4.5 oz/128 g.
Insight has notified retailers via overnight mail to remove any remaining recalled product from shelves and follow the instructions provided in the Drug Recall Notification. The company will also offer reimbursement for consumers who have purchased TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid marked with one of the lot codes in the table above.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Insight is recalling these products out of an abundance of caution. To date, the Company has not received any serious adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.

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: Insight Pharmaceuticals
Brand name: TING®
Product recalled: 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid
Reason of the recall: Presence of benzene
FDA Recall date: February 02, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insight-pharmaceuticals-issues-voluntary-nationwide-recall-tingr-1-tolnaftate-athletes-foot-spray

#drugs #recall #us

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