Recalls / Class I
Class ID-0159-2024
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
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.
- Brand name
- Blistex
- Generic name
- Tolnaftate
- Active ingredient
- Tolnaftate
- Route
- Topical
- NDC
- 10157-4645
- FDA application
- M005
- Affected 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
Why it was recalled
Chemical contamination: Presence of benzene
Recalling firm
- Firm
- Blistex Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1800 Swift Dr, N/A, Oak Brook, Illinois 60523-1577
Distribution
- Quantity
- 243,386 cases (7 6-pack cases; 36 12-pack cases; 2,678,430 cans total)
- Distribution pattern
- Nationwide with the USA, Canada and Korea
Timeline
- Recall initiated
- 2021-11-17
- FDA classified
- 2023-12-21
- Posted by FDA
- 2023-12-27
- Terminated
- 2024-07-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0159-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.