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Recall Observatory FDA recall evidence

Drug product

Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2.

D-0249-2022

October 01, 2021

Class I

Product summary

Firm
Bayer Healthcare Pharmaceuticals Inc.
Event
Event 88677
Status
Terminated
Classification
Class I
Quantity
579,456 cans
Official record key
drug-enforcement:D-0249-2022

Official wording

Reason: Chemical Contamination: presence of benzene

Code information: Lot # TN0023D, EXP 2/28/2022; TN004BX, EXP 6/30/2022;

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