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Recall Observatory FDA recall evidence

Drug 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.

D-0159-2024

November 17, 2021

Class I

Product summary

Firm
Blistex Inc
Event
Event 89055
Status
Terminated
Classification
Class I
Quantity
243,386 cases (7 6-pack cases; 36 12-pack cases; 2,678,430 cans total)
Official record key
drug-enforcement:D-0159-2024

Official wording

Reason: Chemical contamination: Presence of benzene

Code information: 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

Distribution pattern: Nationwide with the USA, Canada and Korea

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical contamination