LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whip
Summary
The FDA issued a Class II for LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) by Bayer Healthcare Pharmaceuticals Inc.. Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene..
Details
Source
Drug Recall
External ID
D-0237-2022
Action Date
2021-11-24
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: 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;
Quantity Affected: 4,546,152 cans
Reason for Recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Distribution
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-01
Company
Whippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 178 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Bayer Healthcare Pharmaceuticals Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bayer Healthcare Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bayer Healthcare Pharmaceuticals Inc. have FDA actions?
Bayer Healthcare Pharmaceuticals Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0237-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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