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