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
Reported: November 24, 2021 Initiated: October 1, 2021 #D-0241-2022
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
Reason for Recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Details
- Recalling Firm
- Bayer Healthcare Pharmaceuticals Inc.
- Units Affected
- 1,801,332 cans
- Distribution
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- Location
- Whippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Bayer Healthcare Pharmaceuticals Inc.. Units affected: 1,801,332 cans.
Why was this product recalled? ▼
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 24, 2021. Severity: Moderate. Recall number: D-0241-2022.
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