- Company Announcement Date:
- September 03, 2020
- FDA Publish Date:
- September 03, 2020
- Product Type:
- Reason for Announcement:
Recall Reason Description
Possible presence of methanol
- Company Name:
- AJR Trading LLC
- Brand Name:
- Product Description:
AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level.
This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications and tests.
However, in an abundance of caution, these units are being recalled because of possible presence of methanol in other lots of bio aaa Advance Hand Sanitizer.
Risk Statement: Substantial methanol exposure could 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 may be at risk; young children who accidently ingest them and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
To date, AJR Trading has not received reports of adverse events related to this recall.
The product is used as a hand sanitizer to reduce bacteria when soap and water is not available and is packaged in 480 mL plastic bottles UPC 7502272121085. AJR Trading is recalling lot 20DF8307, expiration date April 2022. The product can be identified by the images below. Product was distributed in Miami beginning in April 2020.
AJR Trading is notifying its customers by phone calls, e-mails, and letters. AJR Trading is arranging for refund and destruction of recalled products. Consumers/distributors/retailers that have the above listed lots of bio aaa Hand Sanitizer, which is being recalled, should stop using or distributing the products immediately and mail the products to AJR Trading at the address below for refund:
814 Ponce de Leon Blvd, suite 218. Coral Gables, FL. 33134.
Consumers with questions regarding this recall can contact AJR Trading by phone insert 305-302-8416 or e-mail to [email protected] Monday to Friday from 10:00 am to 5:00 pm Central Time. 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.