🔍 RecallPedia

LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

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 #: CV01BEP, 3/31/2022; CV01D6W, 5/31/2022; CV01EV0, 7/31/2022; TN0004J, 9/30/2022; TN001AE, 11/30/2022; TN003C3, 1/31/2023; TN003C4, 2/28/2023; TN003HT, 3/31/2023; TN003CW, 4/30/2023; TN0045J, 6/30/2023; TN0040C, 7/31/2023; TN004BU, 8/31/2023; TN006MB, 9/30/2022;
  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%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

Product Codes/Lot Numbers:

Lot #: CV01BEP, 3/31/2022; CV01D6W, 5/31/2022; CV01EV0, 7/31/2022; TN0004J, 9/30/2022; TN001AE, 11/30/2022; TN003C3, 1/31/2023; TN003C4, 2/28/2023; TN003HT, 3/31/2023; TN003CW, 4/30/2023; TN0045J, 6/30/2023; TN0040C, 7/31/2023; TN004BU, 8/31/2023; TN006MB, 9/30/2022;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0237-2022

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