Drug recall notice for Lotrimin AF and Tinactin spray products

A physician holds a vial of pills while taking notes at a computer.

To assist you in the care of your patients, we would like to alert you to the recall of all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 and September 2021, on Oct. 1, 2021.1 We recommend you review your medical records and contact all patients for whom you have prescribed this medication to warn them of the recall.

The drug manufacturer, Bayer U.S. LLC, is voluntarily recalling these products at the consumer level due to the presence of benzene in some samples of the products.

Benzene is classified as a human carcinogen. Depending on duration and level of exposure, it can result in cancers, including leukemia, blood cancer of the bone marrow and blood disorders. To date, Bayer has no known reports of adverse events related to this recall.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Medications included in this recall

Visit the FDA website for specific details about the recalled medication.

Recommendations

Other lot numbers for these products are unaffected and remain available.

Information for providers:1

  • Healthcare providers with questions can contact Bayer U.S. LLC by calling 866-360-3266, Monday – Friday, 8 a.m. – 8 p.m., Eastern time.
  • Patients may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
    • Online: Complete and submit the report.
      • Select “Consumer/Patient (FDA Form 3500B).”
    • Regular mail or fax: Download the form.
      • Select “Form FDA 3500B – Voluntary Reporting for Consumers” and submit by mail to the address on the form or by fax to 800-FDA-0178 (332-0178).

Reference:

  1. “Bayer Issues Voluntary Recall of Specific Lotrimin® and Tinactin® Spray Products Due to the Presence of Benzene,” U.S. Food and Drug Administration, last accessed Oct. 6, 2021, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-specific-lotriminr-and-tinactinr-spray-products-due-presence-benzene.