Albek de Mexico S.A. de C.V. Issues Voluntary Nationwide Recall of All Hand Sanitizers Due to Potential Presence of Undeclared Methanol

COMPANY ANNOUNCEMENT

Summary

• Company Announcement Date: July 31, 2020
• FDA Publish Date: August 18, 2020
• Product Type: Drugs
• Reason for Announcement: Undeclared Methanol
• Company Name: ALBEK de Mexico S.A. de C.V.
• Brand Name: Nuuxsan, Modesa, more
• Product Description: Hand Sanitizer

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Company Announcement

SAN JUAN del RIO QUERETARO, Mexico -- ALBEK de Mexico S.A. de C.V. is voluntarily recalling all lots and all brands of hand sanitizer currently in US distribution to the consumer level. The products were manufactured between November 7, 2019 and June 28, 2020.

This recall is being initiated out of an abundance of caution due to detection of methanol in hand sanitizer samples manufactured by Albek when product was presented for import into the United States.

Risk Statement: Substantial methanol exposure could result in serious health effects (including nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, nervous system damage) or death. Persons using methanol-based products on their hands may be at risk. Young children who accidently ingest them and adolescents and adults who drink such products are most at risk for methanol poisoning. To date, there have been no reports of serious adverse events related to the products in the scope of this recall.

Recalled Products: The products are labeled for use as a hand sanitizer (or “antiseptic”) and are packaged for several nationwide distributors in a variety of formats as indicated in the table as follows:

BRANDS:	Nuuxsan	Modesa	Assured	Assured	Next
Product Name	Nuuxsan Instant Hand Sanitizer	Modesa Hand Sanitizer with Moisturizers and Aloe Vera	Assured Hand Sanitizer Vitamin E and Aloe	Assured Hand Sanitizer Aloe Vera	Next Hand Sanitizer
NDC	72758-005-02, 72758-001-08	72758-011-23	72758-010-23	72758-009-23	50066-605-08
Sizes	8 fl oz	8 fl oz	8 fl oz	8 fl oz	8 fl oz
UPC	713620000175	32251380426	639277928597	639277928610	650240053573
Affected Lots	All Lot #s	1931104AL	1931101AL	1931102AL	The affected lots end in: 1001, 1002, 1003, 1004, 1005

These products were distributed nationwide in the United States beginning on November, 15 2019.

Albek is partnering with its distributors, who will help notify their customers by phone calls, emails, and/or mailed letters and is arranging for return of all recalled products. Consumers, distributors, and retailers that have product which is being recalled should stop use or distribution and return to place of purchase.

Consumers with questions regarding this recall can contact Albek de Mexico S.A. de C.V. during the business hours business hours: 9:00am – 5:00pm (CT)

 

Email: contact@albek.com.mx

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these products.

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

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Company Contact Information

• Consumers: Albek de Mexico S.A. de C.V.; (713)961-0262; contact@albek.com.mx

• Media: Manuel Beltrán M. ; 52 1 427 101 8200 ext. 102

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