FDA Recall D-0346-2024

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Tarrytown, NY

Class I — life-threatening Completed 833 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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

Lot / code: Lot # 0H50545, Exp. date 07/31/24; 1G50645, Exp. date 06/30/25

Quantity: 59,644 cans

Reason for recall

Chemical Contamination; presence of benzene.

Recall record

Recall number: D-0346-2024
Classification: Class I
Status: Completed
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product was distributed nationwide and to 4 foreign accounts. Guaynabo, Puerto Rico; Georgetown, Guyana; Baghdad, Iraq; Accra, Ghana.
Recall initiated: 2024-02-01
Classified by FDA Center: 2024-02-22
FDA published: 2024-02-28
Recalling firm: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Firm location: Tarrytown, NY

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