Lotrimin AF Powder Spray Recalled for Benzene Contamination
Bayer Healthcare is recalling Lotrimin AF miconazole nitrate 2% powder spray due to the presence of benzene chemical contamination. The recall affects approximately 3.8 million cans distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I by the agency, which mandates a severity score of at least 4. Benzene is a known carcinogen and a chemical contaminant in an inhalable drug product represents a serious health risk to users.
Plain-English summary
Bayer Healthcare Pharmaceuticals Inc. is recalling Lotrimin AF (miconazole nitrate 2%) powder spray in 133g (4.6 oz) cans due to chemical contamination. The recalled product contains benzene, a harmful chemical that should not be present in the medication.
The affected product was distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through various retail channels. The recall involves specific lot numbers: CV01AP2 (expiration 2/28/2022), TN006TD (expiration 3/31/2023), TN008CV (expiration 4/30/2023), and TN008CW (expiration 5/31/2023). The product is identified by NDC 11523-0544-2 and UPC 3 11017 41025 7.
Consumers who have purchased this product should stop using it immediately. Those with questions or concerns should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- 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
- Manufacturer
- Bayer Healthcare Pharmaceuticals Inc.
- Category
- Drug — Topical antifungal spray
- Hazard
- benzene-contamination
- chemical-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot # CV01AP2
- EXP 2/28/2022
- TN006TD
- EXP 3/31/2023
- TN008CV
- EXP 4/30/2023
- TN008CW
- EXP 5/31/2023
Distribution
Distributed nationwide across the United States.
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