FDA Recall D-0159-2024

Blistex Inc · Oak Brook, IL

Class I — life-threatening Terminated 974 days on record

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

Lot / code: 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: 243,386 cases (7 6-pack cases; 36 12-pack cases; 2,678,430 cans total)

Reason for recall

Chemical contamination: Presence of benzene

Recall record

Recall number: D-0159-2024
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide with the USA, Canada and Korea
Recall initiated: 2021-11-17
Classified by FDA Center: 2023-12-21
FDA published: 2023-12-27
Terminated: 2024-07-18
Recalling firm: Blistex Inc
Firm location: Oak Brook, IL

Drug identification

Brand name(s): BLISTEX
Generic name(s): TOLNAFTATE
Manufacturer(s): Blistex Inc
NDC(s): 10157-4645
Route(s): TOPICAL

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