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Recall Observatory FDA recall evidence

Drug product

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105

D-0250-2022

October 01, 2021

Class I

Product summary

Firm
Bayer Healthcare Pharmaceuticals Inc.
Event
Event 88677
Status
Terminated
Classification
Class I
Quantity
738,432 cans
Official record key
drug-enforcement:D-0250-2022

Official wording

Reason: Chemical Contamination: presence of benzene

Code information: Lot # TN0067A, EXP 2/28/2023; TN008CU, 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