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Recall Observatory FDA recall evidence

Drug product

LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3

D-0236-2022

October 01, 2021

Class II

Product summary

Firm
Bayer Healthcare Pharmaceuticals Inc.
Event
Event 88677
Status
Terminated
Classification
Class II
Quantity
2,817,468 cans
Official record key
drug-enforcement:D-0236-2022

Official wording

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

Code information: Lot # TN00082, Exp 9/30/2021;TN000TU, TN000TV, Exp. 10/31/2021; TN00236, Exp. 1/31/2022; TN003C8, Exp 2/28/2022; TN003C9, Exp 3/31/2022; TN003GS, Exp 4/30/2022; TN0041W, Exp 6/30/2022; TN006W8, Exp 8/31/2022; TN005P5, Exp 9/30/2022; TN006MZ, Exp 2/28/2023;

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

    contaminated with benzene
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations