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Recall Observatory FDA recall evidence

Drug product

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5

D-0252-2022

October 01, 2021

Class I

Product summary

Firm
Bayer Healthcare Pharmaceuticals Inc.
Event
Event 88677
Status
Terminated
Classification
Class I
Quantity
592,416 cans
Official record key
drug-enforcement:D-0252-2022

Official wording

Reason: Chemical Contamination: presence of benzene

Code information: Lot # TN008M0, EXP 4/30/2023

Distribution pattern: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination