- Company Announcement Date:
- July 30, 2020
- FDA Publish Date:
- July 31, 2020
- Product Type:
- Reason for Announcement:
Recall Reason Description
- Company Name:
- Albek de Mexico S.A. de C.V
- Brand Name:
Nuuxsan, Modesa, Assured, more
- Product Description:
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 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.
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:
|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|
|Package Format(s)||8 fl oz plastic bottles||8 fl oz plastic bottles||8 oz. plastic bottles<||8 oz. plastic bottles||8 oz. plastic bottles|
|Afected Lot Number(s)||All Lots||1931104AL||1931101AL||1931102AL||The affected lots are those that end 1001,|
1002, 1003, 1004, 1005.
UPC and Lot
|Assured Hand Sanitizer with Vitamin E and Aloe||72758-010-23||639277928597||8 oz. plastic bottles|
|Modesa Hand Sanitizer with Moisturizers and Aloe Vera||72758-011-23||639277928610||8oz. plastic bottles|
|Modesa Hand Sanitizer with Moisturizers and 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.
The 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 Mrs. Susana Luna (713)961-0262, [days of week] from [state time and zone] or e-mail to firstname.lastname@example.org. 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.