Monistat-Derm FDA Alerts

Voluntary Recall of Certain Family Dollar Over-the-Counter Products

July 21, 2022 -- Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled temperature requirements.

To date, Family Dollar has not received any consumer complaints or reports of illness related to this recall.

A list of the recalled products is attached. This recall goes to the retail store level.

Family Dollar has notified its affected stores asking them to check their stock immediately and to quarantine and discontinue the sale of any affected product. Customers that may have bought affected product may return such product to the Family Dollar store where they were purchased without receipt. This recall does not apply to Delaware, Alaska, Hawaii as no Family Dollar stores in Delaware received any products subject to this recall and Family Dollar does not have any stores in Alaska or Hawaii.

Customers with questions regarding this recall may contact Family Dollar Customer Service at 844-636-7687 between 9am and 5pm EST. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
• https://www.fda.gov/safety/report-problem-fda

List of Recalled Products

Source: FDA

Bayer Issues Voluntary Recall of Specific Lotrimin® and Tinactin® Spray Products Due to the Presence of Benzene

WHIPPANY, N.J., October 1, 2021 -- Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia, and blood cancer of the bone marrow and blood disorders which can be life-threatening. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally. To date, Bayer has no known reports of adverse events related to this recall.

The affected Lotrimin® and Tinactin® spray products are over the counter antifungal products, sold individually or in combo packs. The impacted products are:

• Lotrimin® Anti-Fungal (AF) Athlete's Foot Powder Spray
• Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete's Foot Powder Spray
• Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
• Lotrimin® AF Athlete's Foot Liquid Spray
• Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray
• Tinactin® Jock Itch (JI) Powder Spray
• Tinactin® Athlete’s Foot Deodorant Powder Spray
• Tinactin® Athlete’s Foot Powder Spray
• Tinactin® Athlete’s Foot Liquid Spray

Product images and information on which lot numbers fall under this recall are available at: bayer.com

There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.

The recalled products are all packaged in aerosol spray cans. The products were distributed in the U.S., Puerto Rico, Canada and Mexico through a variety of retail channels.

Bayer is also notifying its distributors and retailers by letter and is arranging for returns of all voluntarily recalled products. Consumers may request a refund by visiting www.lotrimin.com or www.tinactin.com, and may contact Bayer with questions by calling 1-866-360-3266, Monday-Friday between the hours of 8 a.m. and 8 p.m. Eastern Time. A photo of the product will be required to receive a refund. After taking your photo and completing the refund process, please discard the product appropriately. Consumers who have the products that are being recalled should stop using. Consumers should contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol antifungal products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Source: FDA