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Safety Report: ALBEK de Mexico S.A. de C.V. Hand Sanitizer - recalled due to undeclared Methanol, USA

3 years ago source fda.gov

Recall notice

United States

Company name: ALBEK de Mexico S.A. de C.V.
Brand name: Nuuxsan, Modesa, more
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: August 18, 2020
Recall details: 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. Check the link below to see the full list of recalled products.

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.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/albek-de-mexico-sa-de-cv-issues-voluntary-nationwide-recall-all-hand-sanitizers-due-potential

Source: FDA

#drugs #handsanitizer #us

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