STATES:   Nationwide in the United States beginning on November 15, 2019.

RECALL:   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. 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 accidentally 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.

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:

Item               Nuuxsan           Mondesa                 Assured            Assured           Next

Product          Instant Hand     Mondesa Hand Sanitizer      Assured Hand     Assured Hand    Next Hand

Name             Sanitizer          with Moisturizers &    Sanitizer Vit. E    Sanitizer Aloe      Sanitizer

                                            Aloe Vera                and Aloe           Vera                                   

NDC               72758-005-02   72758-011-23          72758-010-23    72758-009-23    50066-605-08

                     72758-001-08

Package         8 fl oz plastic    8 fl oz plastic           8 oz plastic       8 oz plastic          8 oz plastic

format(s)       bottles             bottles                    bottles             bottles           bottles

UPC               713620000175     32251380426          639277928597   639277928610    650240053573

Afected        All Lots             1931104AL              1931101AL       1931102AL         Affected Lots end

Lot  #'s                                                                                                       1001 thru 1005

                 PRODUCT NAME                                   NDC             UPC and Lot        Volume/Package   

Assured Hand Sanitizer w/Vitamin E & Aloe             72758-010-23   639277928597    8 oz. plastic bottles

Modesa Hand Sanitizer w/Moisturizers & Aloe Vera   72758-011-23   639277928610    8oz. plastic bottles

Modesa Hand Sanitizer w/Moisturizers & Vitamin E   72758-012-23   Never Produced

Next Hand Sanitizer                                              50066-605-08  650240053573    8oz. plastic bottles

Assured Hand Sanitizer Aloe Vera                           72758-009-23  639277928610    8 oz. plastic bottles

Nuuxsan Instant Hand Sanitizer                             72758-005-02  713620000175    8oz. plastic bottles

NuuxSan Instant Hand Sanitizer                             72758-001-08  713620000175    8oz. plastic bottles

 

This NDC was created in 2019 and then replaced by NDC 72758-002-08.

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. 

ACTION:   Stop using; return to place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these products. 

CONTACT:   Mrs. Susana Luna (713)961-0262, [days of week] from [state time and zone] or e-mail to contact@albek.com.mx.

1-386-428-0300              New Smyrna Beach, Florida

(c) 2009 by Helps4Health LLC 

All Rights Reserved