FDA Recall D-0248-2022

Bayer Healthcare Pharmaceuticals Inc. · Whippany, NJ

Class I — life-threatening Terminated 633 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

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

Quantity: 3,816,468 cans

Reason for recall

Chemical Contamination: presence of benzene

Recall record

Recall number: D-0248-2022
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Recall initiated: 2021-10-01
Classified by FDA Center: 2021-11-18
FDA published: 2021-11-24
Terminated: 2023-06-26
Recalling firm: Bayer Healthcare Pharmaceuticals Inc.
Firm location: Whippany, NJ

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