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Recall Observatory FDA recall evidence

Drug product

LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

D-0237-2022

October 01, 2021

Class II

Product summary

Firm
Bayer Healthcare Pharmaceuticals Inc.
Event
Event 88677
Status
Terminated
Classification
Class II
Quantity
4,546,152 cans
Official record key
drug-enforcement:D-0237-2022

Official wording

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

Code information: Lot #: CV01BEP, 3/31/2022; CV01D6W, 5/31/2022; CV01EV0, 7/31/2022; TN0004J, 9/30/2022; TN001AE, 11/30/2022; TN003C3, 1/31/2023; TN003C4, 2/28/2023; TN003HT, 3/31/2023; TN003CW, 4/30/2023; TN0045J, 6/30/2023; TN0040C, 7/31/2023; TN004BU, 8/31/2023; TN006MB, 9/30/2022;

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