COMPANY ANNOUNCEMENT

ITECH 361 Issues Voluntary Nationwide Recall of All Clean Hand Sanitizer and Moisturizer and Disinfectant Due to The Potential Presence of Undeclared Methanol (Wood Alcohol)

Summary

Company Announcement Date:

July 06, 2020

FDA Publish Date:

July 06, 2020

Product Type:

Drugs

Reason for Announcement:

Potential presence of methanol (wood alcohol).

Company Name:

ITECH 361

Brand Name:

All Clean

Product Description:

Hand sanitizer

Company Announcement

ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: 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 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 To date ITECH 361 has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer and moisturizer and is packaged in one (1) liter plastic bottles with UPC Code 628055370130. All Clean Hand Sanitizer and Moisturizer was distributed Nationwide to wholesale distributors and retailers.

ITECH 361 is notifying its distributors by a Notice of a voluntary recall and consumers via this press release. ITECH 361 is arranging for return/replacement or refund of all recalled products.

Consumers/distributors/retailers that have the product subject to this recall should stop using All Clean Hand Sanitizer, Moisturizer and Disinfectant and return it to the place of purchase.

Consumers with questions regarding this recall can contact Corina Enriquez by phone number (888)405-4442 or e-mail at corina@itech361.com, Monday through Friday beginning July 6, 9:00a.m. to 5:00 p.m. (MDT). 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.

CDER’s Announcement

Company Contact Information

Consumers:

Corina Enriquez

(888)405-4442

 corina@itech361.com

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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.