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%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
Lot numbers, UPCs & expiration codes
Lot # TN00082, Exp 9/30/2021;TN000TU, TN000TV, Exp. 10/31/2021; TN00236, Exp. 1/31/2022; TN003C8, Exp 2/28/2022; TN003C9, Exp 3/31/2022; TN003GS, Exp 4/30/2022; TN0041W, Exp 6/30/2022; TN006W8, Exp 8/31/2022; TN005P5, Exp 9/30/2022; TN006MZ, Exp 2/28/2023;
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-0236-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 1, 2021
- FDA report date
- Nov 24, 2021
- Quantity
- 2,817,468 cans
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0236-2022, 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 # TN00082, Exp 9/30/2021;TN000TU, TN000TV, Exp. 10/31/2021; TN00236, Exp. 1/31/2022; TN003C8, Exp 2/28/2022; TN003C9, Exp 3/31/2022; TN003GS, Exp 4/30/2022; TN0041W, Exp 6/30/2022; TN006W8, Exp 8/31/2022; TN005P5, Exp 9/30/2022; TN006MZ, Exp 2/28/2023;
- Postal code
- 07981-1544
- Report date
- Nov 24, 2021
- Product type
- Drugs
- Recall number
- D-0236-2022
- Classification
- Class II
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Product quantity
- 2,817,468 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%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
- 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