TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Ph
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Summary
The FDA issued a Class I for TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company. Reason: Chemical Contamination; presence of benzene..
Details
Source
Drug Recall
External ID
D-0346-2024
Action Date
2024-02-28
Status
Completed
Category
drug
Product Description
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 Info: Lot # 0H50545, Exp. date 07/31/24; 1G50645, Exp. date 06/30/25
Quantity Affected: 59,644 cans
Reason for Recall
Chemical Contamination; presence of benzene.
Distribution
Product was distributed nationwide and to 4 foreign accounts. Guaynabo, Puerto Rico; Georgetown, Guyana; Baghdad, Iraq; Accra, Ghana.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-01
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company have FDA actions?
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0346-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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