Company Announcement Date: July 14, 2020

FDA Publish Date: July 14, 2020

Product Type: Drugs

Reason for Announcement: Potential Undeclared Methanol Contamination

Company Name: AAA Cosmetica, S.

A. de C.V.

Brand Name: bio aaa

Product Description: Hand Sanitizer

AAA Cosmetica, S.A. de C.V. is voluntarily recalling all lots of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure could result in nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Persons using these products on their hands may be at risk; however young children who accidently ingest them and adolescents and adults who drink these products are most at risk for methanol poisoning. To date, AAA Cosmetica has not received any complaints or adverse event reports related to this recall.

The product is used as a hand sanitizer and it is packaged in 480 mL plastic bottles.  AAA Cosmetica is recalling the following bio aaa Advance Hand Sanitizer lots, all of which bear the expiration date of April 2022:

The product can be identified by the images. Product was distributed Nationwide in the United States beginning in April 2020.

AAA Cosmetica has notified its distributor, who will help notify its customers by phone calls, emails, and letters. AAA Cosmetica is arranging for refund and destruction of recalled products. Consumers/distributors/retailers that have the above listed lots of bio aaa Hand Sanitizer should stop using or distributing the products immediately and mail the products to AAA Cosmetica at the address below for refund:

I.S.C. Forwarder Inc.
8400 San Lorenzo,
Laredo, Texas 78045
(956) 753 0225

Consumers with questions regarding this recall can contact AAA Cosm?ca by phone +525526281124 or e-mail to customerservice@aaacosmetica.com.mx 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.

Link to CDER Public Notice