Nanomateriales, Sa De CV Issues Voluntary Nationwide Recall of All Lots of Zanilast+gel Due to the Presence of 1-Propanol

Summary

Company Announcement Date:

August 26, 2020

FDA Publish Date:

August 26, 2020

Product Type:

Drugs

Reason for Announcement:

Product contains 1-propanol.

Company Name:

Nanomateriales, SA de CV

Brand Name:

Zanilast+

Product Description:

Hand sanitizer

Company Announcement

Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL, Sanitizer gel, to the consumer level. FDA laboratory analysis found ZANILAST+ GEL to contain 1-propanol.

Risk Statement: There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention. Populations most at risk include individual with alcohol addiction and adolescents, who have been known to ingest ethanol-based antiseptic rubs intentionally to become intoxicated, as well as infants and children who may unintentionally ingest the defective product. Nanomateriales, SA de CV has not received any reports of adverse events related to this recall.

The product is used as a sanitizer gel, for hand washing to decrease bacteria on the skin and is packaged in 1 liter, 25 liters, and 1 gallon plastic bottles distributed from 05/29/2020 to 06/17/2020 in the States of California, New York and New Jersey.

Nanomateriales, SA de CV is notifying its distributors and customers by e-mail and phone and is arranging for return of all recalled products. Consumers and distributors that have ZANILAST+ GEL which is being recalled should return to place of purchase.

Consumers with questions regarding this recall can contact Nanomateriales SA de CV by phone (+1 (210)963 5679) or e-mail (contacto@nanomateriales.com.mx) on working days (Monday through Friday) from 10:00 AM to 5:00 PM, Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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.

CDER’s press statement

Company Contact Information

Consumers:

Nanomateriales SA de CV

+1-210-963-5679

 contacto@nanomateriales.com.mx

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nanomateriales-sa-de-cv-issues-voluntary-nationwide-recall-all-lots-zanilastgel-due-presence-1?utm_campaign=Nanomateriales%2C%20Sa%20De%20CV%20Issues%20Voluntary%20Nationwide%20Recall%20of%20All%20Lots%20of%20Zanilast%2Bgel&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.
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About Feeding America Recall Notices

The Feeding America national office issues notifications of all national Class I and II recalls–those involving a health hazard situation in which there is reasonable probability that eating the food will cause health problems or death–and other recalls that may affect the safety of food supplied to network members.

The national office strongly encourages all member product solicitors, operations managers, and others involved in food and grocery distribution to regularly consult resources provided by the United States Food and Drug Administration (FDA) at https://www.fda.gov/opacom/7alerts.html, and the United States Department of Agriculture (USDA) at https://www.fsis.usda.gov/Fsis_Recalls/index.asp. Additionally, members can often receive information on national, state, and local recalls by contacting their local health departments.

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