Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot # (a) TN000TR, EXP 10/31/2021; TN0011B, EXP 11/30/2021; TN003CC, TN003CD, EXP 02/28/2022; TN0040B, EXP 05/31/2022; TN0041U, EXP 06/30/2022; TN004BK, EXP 08/31/2022; TN005P3, EXP 10/31/2022; TN006AP, TN006MC, EXP 01/31/2023; TN006TB, EXP 04/30/2023; (b) TN000TR, EXP 10/31/2021; TN0011B, TN0011BA, EXP 11/30/2021; TN003CD, TN003CDA, TN003CDB,EXP 02/28/2022; TN0040BA, TN0040BV, EXP 05/31/2022; TN0041U,EXP 06/30/2022; TN004BK, EXP 08/31/2022; TN006MC, EXP 01/31/2023;
Where it was sold
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0241-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 1, 2021
- FDA report date
- Nov 24, 2021
- Quantity
- 1,801,332 cans
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0241-2022, exactly as published.
Show all FDA fields
- City
- Whippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88677
- Address
- 100 Bayer Blvd
- Code information
- Lot # (a) TN000TR, EXP 10/31/2021; TN0011B, EXP 11/30/2021; TN003CC, TN003CD, EXP 02/28/2022; TN0040B, EXP 05/31/2022; TN0041U, EXP 06/30/2022; TN004BK, EXP 08/31/2022; TN005P3, EXP 10/31/2022; TN006AP, TN006MC, EXP 01/31/2023; TN006TB, EXP 04/30/2023; (b) TN000TR, EXP 10/31/2021; TN0011B, TN0011BA, EXP 11/30/2021; TN003CD, TN003CDA, TN003CDB,EXP 02/28/2022; TN0040BA, TN0040BV, EXP 05/31/2022; TN0041U,EXP 06/30/2022; TN004BK, EXP 08/31/2022; TN006MC, EXP 01/31/2023;
- Postal code
- 07981-1544
- Report date
- Nov 24, 2021
- Product type
- Drugs
- Recall number
- D-0241-2022
- Classification
- Class II
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Product quantity
- 1,801,332 cans
- Termination date
- Jun 26, 2023
- Reason for recall
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Oct 1, 2021
- Initial firm notification
- Press Release
- Center classification date
- Nov 18, 2021