Asiaticon SA de CV Issues Voluntary Nationwide Recall of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels - 8/28/20

Summary

Company Announcement Date:

August 25, 2020

FDA Publish Date:

August 25, 2020

Product Type:

Drugs

Reason for Announcement:

Potential presence of methanol (wood alcohol) and subpotent ethanol levels

Company Name:

Asiaticon SA de CV

Brand Name:

V-Klean, Medical Minded, Protz

Product Description:

Hand Sanitizer

Company Announcement

Mexico City, Mexico, Asiaticon SA de CV (Mexico) is voluntarily recalling all lots of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer sold in 13.5, 16.9 and 33.8 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol) and subpotent ethanol levels.

Risk Statement:  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, 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. To date Asiaticon SA de CV has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer and is packaged in plastic clear bottles with clear tops with UPC Code:
V-Klean in 8.5 fl. oz. (250 ml) bottles: 716053704993
V-Klean in 16.9 fl. oz. (500 ml) bottles: 716053704993
V-Klean in 33.8 fl. oz. (1000 ml) bottles: 716053704993
Medically Minded in 16.9 fl. oz. (500 ml) bottles: 676753003782
Protz in 13.5 fl. oz. (400 ml) bottles : 7503019005002
The recall includes all lots.  This product was exported to different distributors nationwide.

Asiaticon SA de CV is notifying its distributors by voluntary recall letter and consumers via this press release. Consumers that have the product subject to this recall should stop using and either contact Asiaticon SA de CV per the below for disposal instructions or return it to the place of purchase.

Consumers with questions regarding this recall can contact Asiaticon SA de CV at direccion@asiatic-connection.com (0052 1 55 21553488).  In the US: at 929 394 3020 (available Monday to Friday 9.30 am  6 pm eastern time) Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this 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 formor 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.

Link to CDER’s press statement: FDA updates on hand sanitizers consumers should not use

Company Contact Information

Consumers:

Asiaticon SA de CV

0052155 21553488, In the US: at 929 394 3020

 direccion@asiatic-connection.com

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/asiaticon-sa-de-cv-issues-voluntary-nationwide-recall-v-klean-hand-sanitizer-gel-medically-minded?utm_campaign=Asiaticon%20SA%20de%20CV%20Issues%20Voluntary%20Nationwide%20Recall%20of%20V-Klean&utm_medium=email&utm_source=Eloqua

 

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* We believe that none of the product being recalled were processed or offered through the national office
* We strongly encourage you to notify your agencies within one business day from receipt of this notice.
* ALL cased and uncased inventories, both at the member level and agency level, need to be checked. This product may have entered member and agency warehouses through salvage, local donations, TEFAP, local purchases, retail pickups, food drives, or other avenues.
* For additional local details, please contact the Health Department(s) for the area(s) your food bank serves.
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About Feeding America Recall Notices

The Feeding America national office issues notifications of all national Class I and II recalls–those involving a health hazard situation in which there is reasonable probability that eating the food will cause health problems or death–and other recalls that may affect the safety of food supplied to network members.

The national office strongly encourages all member product solicitors, operations managers, and others involved in food and grocery distribution to regularly consult resources provided by the United States Food and Drug Administration (FDA) at http://www.fda.gov/opacom/7alerts.html, and the United States Department of Agriculture (USDA) at http://www.fsis.usda.gov/Fsis_Recalls/index.asp. Additionally, members can often receive information on national, state, and local recalls by contacting their local health departments.

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