- Company Announcement Date:
- August 26, 2020
- FDA Publish Date:
- August 26, 2020
- Product Type:
- Reason for Announcement:
Product contains 1-propanol.
- Company Name:
- Nanomateriales, SA de CV
- Brand Name:
- Product Description:
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 kg, and 1 gallon plastic bottles distributed from 05/29/2020 to 06/17/2020 in the States of California, New York and New Jersey.
|1 liter||2 000000 531151||69912-008-01||See below|
|25 kg||69912-006-01||See below|
|1 gallon||2 000000 531144||69912-008-02||See below|
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 ([email protected]) 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 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.