Bayer Healthcare Pharmaceuticals Inc.: Drug Recall

Recall #D-0241-2022 · 10/01/2021

Class II: Risk

Recall Details

Recall Number: D-0241-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Bayer Healthcare Pharmaceuticals Inc.
Status: Terminated
Date Initiated: 10/01/2021
Location: Whippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,801,332 cans

Reason for Recall

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

Product Description

Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain

Distribution Pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

Other Recalls by Bayer Healthcare Pharmaceuticals Inc.

Class I: Dangerous 11/06/2023

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Class I: Dangerous 10/01/2021

Chemical Contamination: presence of benzene
Class I: Dangerous 10/01/2021

Chemical Contamination: presence of benzene
Class II: Risk 10/01/2021

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class I: Dangerous 10/01/2021

Chemical Contamination: presence of benzene

View all recalls by Bayer Healthcare Pharmaceuticals Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.