Why it was recalled
Chemical Contamination: presence of benzene
Product description
LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7
Lot numbers, UPCs & expiration codes
Lot # CV01AP2, EXP 2/28/2022; TN006TD, EXP 3/31/2023; TN008CV, EXP 4/30/2023; TN008CW, EXP 5/31/2023;
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-0248-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 1, 2021
- FDA report date
- Nov 24, 2021
- Quantity
- 3,816,468 cans
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0248-2022, 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 # CV01AP2, EXP 2/28/2022; TN006TD, EXP 3/31/2023; TN008CV, EXP 4/30/2023; TN008CW, EXP 5/31/2023;
- Postal code
- 07981-1544
- Report date
- Nov 24, 2021
- Product type
- Drugs
- Recall number
- D-0248-2022
- Classification
- Class I
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Product quantity
- 3,816,468 cans
- Termination date
- Jun 26, 2023
- Reason for recall
- Chemical Contamination: presence of benzene
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7
- 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