- Company Announcement Date:
- April 01, 2022
- FDA Publish Date:
- April 01, 2022
- Product Type:
- Reason for Announcement:
Recall Reason Description
Presence of Methanol in Mickey Mouse and Presence of Benzene in The Mandalorian
- Company Name:
- Best Brands Consumer Products, Inc.
- Brand Name:
Mickey Mouse, The Mandalorian
- Product Description:
Best Brands Consumer Products, Inc. is voluntarily recalling two (2) finished product lots of The Mandalorian Hand Sanitizer Ethyl Alcohol 68%, available in green and blue formulations and Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% blue formulation to the consumer level. FDA testing found the presence of benzene in The Mandalorian Hand Sanitizer product and methanol in the Mickey Mouse Hand Sanitizer product. Best Brands imported these two lots, which were produced by a third-party manufacturer.
Benzene is classified as a human carcinogen. Substantial exposure to benzene can occur through inhalation, oral, and skin and it may result in cancers including leukemia and blood cancer of the bone marrow and blood disorders, which can be life-threatening.
Substantial exposure to methanol can result in nausea, vomiting, headache, blurred vision, coma, seizures, permanent blindness, permanent damage to the central nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products, and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
Upon being notified of the testing results by FDA in late February, 2022, Best Brands promptly investigated and determined that both of the affected lots were produced during the months of April and May, 2020 and confirmed that the affected lots had already been removed from sale in April 2021 for unrelated commercial reasons.
To date, Best Brands has not received any reports of adverse events related to these voluntarily recalled lots, or for any other finished product lots of its Ethyl Alcohol 68% Hand Sanitizer products.
The Mandalorian Hand Sanitizer available in green and blue formulations and Mickey Mouse Hand Sanitizer are used to help reduce microorganisms that can potentially cause illness when regular hand hygiene measures (i.e., washing with soap and water for at least 20 seconds) are not readily available or feasible and is packaged in 2.11fl. oz/60 mL bottles. The voluntarily recalled finished product lots and expiration dates are listed in the table below. The product, which was distributed nationwide via three retail outlets, has since been removed from sale at each outlet for unrelated commercial reasons, and was not further distributed.
|Product||MFG Lot #||EXPIRE DATE||NDC #|
|Mickey Mouse Hand Sanitizer, Ethyl Alcohol 68%, blue color, 2.11 fl. oz bottle||20D21||6/30/2022||74530-013-02|
|The Mandalorian Hand Sanitizer, Ethyl Alcohol 68%, blue/green color, 2.11 fl. oz bottle||20E21||9/30/2022||74530-012-02|
Consumers that have Lot: 20E21 (Exp. 9/30/22) of The Mandalorian Hand Sanitizer Ethyl Alcohol 68%, available in green and blue formulations in 2.11 fl. oz. bottles, and Lot: 20D21 (Exp. 6/30/22) of Mickey Mouse Hand Sanitizer Ethyl Alcohol 68%, available in blue formulation in 2.11 fl. oz. bottles, which is being recalled should stop using and appropriately discard it.
Consumers may contact Best Brands with questions regarding this recall or to request a refund by contacting [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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.
Leave a Reply