Safety Report: Zanilast+ Hand sanitizer - recalled due to Product contains 1-propanol., United States

United States

Company name: Nanomateriales, SA de CV
Brand name: Zanilast+
Product recalled: Hand sanitizer
Reason of the recall: Product contains 1-propanol.
FDA Recall date: August 26, 2020
Recall details: 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.

Presentatio UPC NDC Lable
1 Liter 2 000000 531151 69912-008-01 See below
25 Liter 2 000000 531151 69912-006-01 See below
1 galon 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.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nanomateriales-sa-de-cv-issues-voluntary-nationwide-recall-all-lots-zanilastgel-due-presence-1

Source: FDA