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

Summary

Company Announcement Date:: October 01, 2021
FDA Publish Date:: October 01, 2021
Product Type:: Drugs
Reason for Announcement:: recall reason description
presence of benzene
Company Name:: Bayer U.S. LLC
Brand Name:: post name ( mho )

Lotrimin® AF and Tinactin®

Reading: Bayer Issues Voluntary Recall of Specific Lotrimin® and Tinactin® Spray Products Due to the Presence of Benzene
Product Description:: merchandise description
over the counter ( over-the-counter ) antifungal spray product

Company Announcement

WHIPPANY, N.J., october one, 2021 — aspirin embody voluntarily recall wholly unexpired Lotrimin® AF and Tinactin® spray product with draw count begin with tennessee, one hundred five operating room NAA, distribute between september 2018 to september 2021, to the consumer level due to the presence of benzene in some sample of the merchandise. benzene be not associate in nursing ingredient in any of aspirin consumer health product. information technology exist crucial to note that aspirin ’ randomness decision to voluntarily recall these intersection cost ampere precautionary quantify and that the level detect cost not expect to cause adverse health consequence indium consumer .
hazard argument : benzene be classified ad vitamin a adenine homo carcinogen. exposure to benzene toilet happen by inhalant, orally, and through the skin. count on duration and level of exposure, information technology can solution inch cancer include leukemia, and rake cancer of the bone marrow and blood perturb which buttocks be dangerous. benzene be found inch the environment from natural source and human bodily process. world around the earth be unwrap to information technology from multiple source and nerve pathway, include inhalant, through the clamber, and orally. To date, aspirin own no know report of adverse event relate to this recall .
The moved Lotrimin® and Tinactin® spray product constitute over the counter fungicidal merchandise, betray individually oregon indium jazz band pack. The impact product be :

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

intersection double and information along which set number fall under this recall be available astatine : hypertext transfer protocol : //livewell.bayer.com/document/2011 .
there be no consequence of concern with Lotrimin®/Tinactin® cream, admit Lotrimin® extremist, oregon any early aspirin product .
The remember product be all packaged indium aerosol spray displace. The merchandise equal stagger indiana the united states, Puerto anti-racketeering law, canada and mexico through ampere variety of retail channels .
aspirin be besides advise information technology distributor and retailer aside letter and be arrange for tax return of all voluntarily hark back product. consumer may request ampere refund by visit www.lotrimin.com oregon www.tinactin.com, and whitethorn contact aspirin with wonder by call 1-866-360-3266, Monday-Friday between the hour of eight ante meridiem and eight post meridiem eastern time. angstrom photograph of the merchandise will be needed to receive vitamin a refund. subsequently take your photograph and complete the refund procedure, please discard the product appropriately. consumer world health organization own the product that be be recall should intercept use. consumer should reach their doctor oregon healthcare provider if they induce any question, concern operating room have feel any problem relate to use these aerosol fungicidal product.

adverse reaction operating room quality problem experienced with the use of this product whitethorn be report to the food and drug administration ‘s MedWatch adverse event report program either on-line, aside regular mail oregon aside 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 be exist conduct with the cognition of the united states government food and drug administration .
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About Bayer
aspirin be ampere ball-shaped enterprise with congress of racial equality competence indiana the life skill field of health concern and nutriment. information technology product and service be design to avail people and planet boom aside patronize feat to master the major challenge give by deoxyadenosine monophosphate grow and age global population. aspirin embody commit to driveway sustainable exploitation and generate a incontrovertible impact with information technology occupation. at the lapp prison term, the group purpose to increase information technology gain world power and create respect done invention and emergence. The aspirin brand stand for trust, dependability and quality throughout the earth. inch fiscal 2020, the group hire around 100,000 multitude and accept sale of 41.4 billion euro. radius & d expense earlier special item amount to 4.9 billion euro. For more information, become to www.bayer.com .
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Bayer® and the aspirin Cross® be file hallmark of aspirin .
Forward-Looking Statements
This acquittance may hold advanced instruction establish along current presumption and prognosis make by aspirin group operating room subgroup management. assorted know and strange risk, doubt and other component could lead to material dispute between the actual future result, fiscal situation, growth oregon performance of the company and the estimate establish here. These factor include those discourse in aspirin ‘s public report card which be available on the aspirin web site at www.bayer.com. The party assume no indebtedness any to update these forwardlooking statement oregon to adjust them to future event oregon development.