Recalls / Class I
Class ID-0346-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3
- Affected lot / code info
- Lot # 0H50545, Exp. date 07/31/24; 1G50645, Exp. date 06/30/25
Why it was recalled
Chemical Contamination; presence of benzene.
Recalling firm
- Firm
- Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 660 White Plains Rd Ste 250, N/A, Tarrytown, New York 10591-5171
Distribution
- Quantity
- 59,644 cans
- Distribution pattern
- Product was distributed nationwide and to 4 foreign accounts. Guaynabo, Puerto Rico; Georgetown, Guyana; Baghdad, Iraq; Accra, Ghana.
Timeline
- Recall initiated
- 2024-02-01
- FDA classified
- 2024-02-22
- Posted by FDA
- 2024-02-28
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0346-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.