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Recall Observatory FDA recall evidence

Drug product

LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7

D-0248-2022

October 01, 2021

Class I

Product summary

Firm
Bayer Healthcare Pharmaceuticals Inc.
Event
Event 88677
Status
Terminated
Classification
Class I
Quantity
3,816,468 cans
Official record key
drug-enforcement:D-0248-2022

Official wording

Reason: Chemical Contamination: presence of benzene

Code information: Lot # CV01AP2, EXP 2/28/2022; TN006TD, EXP 3/31/2023; TN008CV, EXP 4/30/2023; TN008CW, EXP 5/31/2023;

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