🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: October 1, 2021 Bayer Healthcare Pharmaceuticals Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bayer Healthcare Pharmaceuticals Inc.
Reason for Recall:
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0241-2022

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