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) - 8/5/20

Summary

Company Announcement Date:

July 30, 2020

FDA Publish Date:

July 31, 2020

Product Type:

Drugs

Reason for Announcement:

Undeclared Methanol

Company Name:

Albek de Mexico S.A. de C.V

Brand Name:

Nuuxsan, Modesa, Assured, more

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:

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 formor 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

Consumers:

Mrs. Susana Luna

(713)961-0262

 contact@albek.com.mx

https://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?utm_campaign=Albek%20de%20Mexico%20S.A.%20de%20C.V.%20Issues%20Voluntary%20Nationwide%20Recall%20of%20All%20Hand%20Sanitizers&utm_medium=email&utm_source=Eloqua

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* We believe that none of the product being recalled were processed or offered through the national office
* We strongly encourage you to notify your agencies within one business day from receipt of this notice.
* ALL cased and uncased inventories, both at the member level and agency level, need to be checked. This product may have entered member and agency warehouses through salvage, local donations, TEFAP, local purchases, retail pickups, food drives, or other avenues.
* For additional local details, please contact the Health Department(s) for the area(s) your food bank serves.