February 2024 FDA Recall Drug by Insight Pharmaceuticals Llc, A Prestige Consumer Healthcare Company
D-0346-2024 - Chemical Contamination; presence of benzene.

This Class I drug recall was voluntarily initiated by Insight Pharmaceuticals Llc, A Prestige Consumer Healthcare Company on February 1, 2024 for the product Drug. The FDA reported the reason for recall as chemical contamination; presence of benzene.. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0346-2024

Reason for Recall
Chemical Contamination; presence of benzene.
Initiated
02-01-2024
Reported
02-28-2024
Quantity
59,644 cans

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93928
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide and to 4 foreign accounts. Guaynabo, Puerto Rico; Georgetown, Guyana; Baghdad, Iraq; Accra, Ghana.
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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