Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-464
Summary
The FDA issued a Class I for Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol by Blistex Inc. Reason: Chemical contamination: Presence of benzene.
Details
Source
Drug Recall
External ID
D-0159-2024
Action Date
2023-12-27
Status
Terminated
Category
drug
Product Description
Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392.
Lot/Code Info: a) Lot #: D19K22, D19K23, Exp. Date 10/21; D19M24, D19M25, D19M26, D19M27, Exp. Date 12/21; D20C01, D20C02, D20C03, D20C04, Exp. Date 3/22; D20F08, D20F09, Exp. Date 6/22; LD20H10, D20H11, Exp. Date 8/22; D20K13, D20K14, Exp. Date 10/22 D21B01, Exp. Date 2/23; D21D03, Exp. Date 4/23; D21E04, D21F04, Exp. Date 5/23; D21F05, Exp. Date 6/23; D21G01, D21G02, Exp. Date 7/23; D21H03, D21H04, D21H05, Exp. Date 8/23. b) Lot #: D19M27, D19M28, D19M29, D19M30, Exp. Date 12/21; D20E05, D20E06, D20E07, Exp. Date 5/22; D20M15, D20M16, Exp. Date 12/22; D21B02, Exp. Date 2/23
Quantity Affected: 243,386 cases (7 6-pack cases; 36 12-pack cases; 2,678,430 cans total)
Reason for Recall
Chemical contamination: Presence of benzene
Distribution
Nationwide with the USA, Canada and Korea
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-17
Company
Oak Brook, IL
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 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Blistex Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Blistex Inc have FDA actions?
This is the only FDA action we have on record for Blistex Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0159-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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