United States
Company name: Roque Plast S.A. de C.V.
Brand name: Command Brands
Product recalled: Hand Sanitizer
Reason of the recall: Methanol Contamination
FDA Recall date: August 04, 2020
Recall details: 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:Â 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:Â Command Brands Gel AntiBac Instant Hand Sanitizer
NDC: 50058-100-08
Package formats (sizes):Â Â 8.4 fl oz (250 mL)
Plastic bottleUPC:Â 8_52239_00689_2
Affected lot (numbers):Â Â 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. Â 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on
www.fda.gov
Source: FDA
