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Jul 18, 2023

Roque Plast S.A. de C.V. Issues Voluntary Nationwide Recall of Command Brands Gel AntiBac Instant Hand Sanitizer Lots 200371

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or

COMPANY ANNOUNCEMENT

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Roque Plast S.A. de C.V. is voluntarily recalling lots 200371-12, 200371OH-05, 170420OH-06, 170420OH-8 manufactured by Roque Plast S.A. de C.V. of Command Brands Gel AntiBac Instant Hand Sanitizer to the consumer level. This recall has been initiated due purported potential presence of methanol indicated by the Food and Drug Administration (FDA) when product was presented for import in the United States. Although, final official FDA analysis results and reports have not been received, out to the abundance of caution and as suggested by the FDA, Roque Plast S.A. de C.V. are recalling lots 200371-12, 200371OH-05,170420OH-06,170420OH-8.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date Roque Plast S.A. de C.V. has not received reports of adverse events related to the products of this recall.

Recalled Products:

Name product: Command Brands Gel AntiBac Instant Hand SanitizerNDC: 50058-100-08Package formats (sizes): 8.4 fl oz (250 mL) Plastic bottleUPC: 8_52239_00689_2Affected lot (numbers): 200371-12, 200371OH-05, 170420OH-06, 170420OH-8

The product is used as a hand sanitizer for hand washing to decrease bacteria on the skin when soap and water are not available. The products are packaged in an 8.4 fl oz (250 mL) PET or High-density polyethylene (HDPE) plastic bottle with UPC 8_52239_00689_2. The product is labeled with a red, blue and yellow stripes with the words Command Brands Gel AntiBac Instant Hand Sanitizer written in yellow and blue letters. The product was distributed nationwide throughout the United States.

Roque Plast S.A. de C.V. is notifying its customers/distributors by recall letter and consumers via this press release. We are also notifying our 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 should contact their physician or healthcare provider if they experienced any problems that may be related to taking or using this product.

Consumers with questions regarding this recall can contact Rafael Cabrera + 52 55 58165506 Ext. 103, Mon-Fri during business hours 9:00 AM - 4:30 PM (CDT) or e-mail to [email protected].

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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

FDA updates on hand sanitizers consumers should not use

08/04/2020

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