Safety Report: TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal SprayPowder - recalled due to presence of benzene, USA

United States

Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling two lots of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder to the consumer level. A recent review by our manufacturer and their third-party lab found that samples from two lots of the product contained elevated levels of benzene. The affected lots were distributed nationwide in the United States through a limited number of retailers and online. To date, the Company has not received any serious adverse events related to this recall.

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. Benzene is ubiquitous in the environment. Humans around the world have daily exposure to it indoors and outdoors from multiple sources.

TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder is packaged in green 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 trace levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Ting products.
Affected products:
- Product: TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder, NDC: 63736-532-05, Lot Code: 0H88645, Expiration: 07/24, Package Size: 4.5 oz/128 g
- Product: TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder, NDC: 63736-532-05, Lot Code: 0B88345, Expiration: 02/24, 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® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray marked with one of the lot codes.

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: 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal SprayPowder
Reason for the recall: Presence of benzene
FDA Recall date: November 24, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insight-pharmaceuticals-issues-voluntary-nationwide-recall-tingr-2-miconazole-nitrate-athletes-foot