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
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 firstname.lastname@example.org.