COMPANY ANNOUNCEMENT
Grupo Yacana México S.A.S De C.V. Issues Voluntary Nationwide Recall of All Lots of Yacana Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Sub-Potent Ethanol
This recall has been completed and FDA has terminated this recall.
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
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Recall Reason DescriptionPotential Presence of Methanol (Wood Alcohol) and sub-potent ethanol
- Company Name:
- Grupo Yacana México S.A.S de C.V.
- Brand Name:
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Brand Name(s)Yacana
- Product Description:
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Product DescriptionYacana Hand Sanitizer, 70% Alcohol
Company Announcement
Guadalupe, Nuevo León, Grupo Yacana México S.A.S de C.V. is voluntarily recalling All Lots of Yacana Hand Sanitizer, 70% Alcohol, 250 ml to the consumer level. The products have the potential to contain methanol (wood alcohol) and be sub-potent for the ethanol content.
Risk Statement: The use of sub-potent hand sanitizer products can have adverse health consequences related to infections. Ethanol levels below the label claim can result in a lack of efficacy. In addition, methanol has inferior antiseptic properties compared to ethanol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all person using these products on their hands are at risk, your 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. To date, Grupo Yacana Mexico S.A. de C.V. has not received any reports of adverse events related to this recall.
The product is used as a hand sanitizer to help reduce bacteria in hands and is packaged in 250 ml bottles, All lots (NDC: 76592-001-01) and All lots (NDC: 76592-002-04) The product can be identified by the label attached in this document. Hand Sanitizer was distributed Nationwide in the USA to Wholesale distributors.
Grupo Yacana México S.A.S de C.V. is notifying its distributors and customers by contacting them by email and sending a letter of Product Recall and is arranging for return of all recalled products. Distributors that have Hand Sanitizer which is being recalled should stop using and return to place of purchase.
Consumers with questions regarding this recall can contact Grupo Yacana México S.A.S de C.V. at 915-320-7016 or calidad@yacana.mx on Monday through Friday from 9 am and 5 pm, CST. 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.
CDER’s press statement: FDA updates on hand sanitizers consumers should not use
Company Contact Information
- Consumers:
- Grupo Yacana México S.A.S de C.V.
- 915-320-7016
