Skip to content
Recall Observatory FDA recall evidence

Drug product

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.

D-0239-2022

October 01, 2021

Class II

Product summary

Firm
Bayer Healthcare Pharmaceuticals Inc.
Event
Event 88677
Status
Terminated
Classification
Class II
Quantity
77,076 cans
Official record key
drug-enforcement:D-0239-2022

Official wording

Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Code information: Lot # TN005K4, EXP 4/30/2022; TN005K8, 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

    contaminated with benzene
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations