Albek de Mexico S.A. de C.V. Issues Voluntary Nationwide Recall of All Hand Sanitizers Within Expiry Due to Potential Presence of Methanol (Wood Alcohol)

Summary

Company Announcement Date:
July 30, 2020
FDA Publish Date:
July 31, 2020
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

Undeclared Methanol

Company Name:
Albek de Mexico S.A. de C.V
Brand Name:

Brand Name(s)

Nuuxsan, Modesa, Assured, more

Product Description:

Product Description

Hand Sanitizer


Company Announcement

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:

Item

Nuuxsan

Modesa

Assured

Assured

Next

Product NameNuuxsan Instant Hand SanitizerModesa Hand Sanitizer with Moisturizers and Aloe VeraAssured Hand Sanitizer Vitamin E and AloeAssured Hand Sanitizer Aloe VeraNext Hand Sanitizer
NDC72758-005-02, 72758-001-0872758-011-2372758-010-2372758-009-2350066-605-08
Package Format(s)8 fl oz plastic bottles8 fl oz plastic bottles8 oz. plastic bottles<8 oz. plastic bottles8 oz. plastic bottles
UPC71362000017532251380426639277928597639277928610650240053573
Afected Lot Number(s)All Lots1931104AL1931101AL1931102ALThe affected lots are those that end 1001,
1002, 1003, 1004, 1005.

Product Name

NDC

UPC and Lot

Volume/Package

Assured Hand Sanitizer with Vitamin E and Aloe72758-010-236392779285978 oz. plastic bottles
Modesa Hand Sanitizer with Moisturizers and Aloe Vera72758-011-236392779286108oz. plastic bottles
Modesa Hand Sanitizer with Moisturizers and Vitamin E72758-012-23Never Produced
Next Hand Sanitizer50066-605-086502400535738oz. plastic bottles
Assured Hand Sanitizer Aloe Vera72758-009-236392779286108 oz. plastic bottles
Nuuxsan Instant Hand Sanitizer72758-005-027136200001758oz. plastic bottles
NuuxSan Instant Hand Sanitizer72758-001-087136200001758oz. 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 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.


Company Contact Information


Product Photos

Article source: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/albek-de-mexico-sa-de-cv-issues-voluntary-nationwide-recall-all-hand-sanitizers-within-expiry-due