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Safety Report: Resource Recovery & Trading, LLC Hand Sanitizer - recalled due to Undeclared Methanol subpotency ethyl alcohol
4 years ago •source fda.gov
Recall notice
Company name: Resource Recovery & Trading, LLC
Brand name: Resource Recover & Trading, LLC
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol subpotency ethyl alcohol
FDA Recall date: July 27, 2020
Recall details: RESOURCE RECOVERY & TRADING LLC, is voluntarily recalling all the lots manufactured by MXL Comercial S.A. de C.V. of Hand Sanitizer with the next information: HAND SANITIZER 70% Ethyl Alcohol Disinfectant Gel, packaged in 6.7 FL Oz. (200 ml) bottles, UPC 650240026020 and HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) liter plastic containers, UPC 37710600013 to the consumer level. The products are being recalled due to the potential presence of undeclared methanol (wood alcohol) and subpotency ethyl alcohol.
Risk Statement: The main concern with the use of hand sanitizer that is sub-potent for ethyl alcohol is the potential for decreased bactericidal and virucidal activity. Adverse health consequences can be related to increased infections. In addition substantial, undeclared methanol exposure, which has inferior antiseptic properties compared to ethanol, 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, RESOURCE RECOVERY & TRADING LLC has not received any reports of adverse events related to this recall. The product is used as a hand sanitizer to decrease germs when soap and water is not available and is packaged in 200 ml plastic bottles and 20 liter plastic containers. The product can be identified by the label attached. The product was distribution between June 10, 2020 and June 20, 2020 in the states of Alabama and Georgia.
RESOURCE RECOVERY & TRADING LLC is notifying its distributors and customers by phone calls and emails and is arranging for return and destruction of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using products, initiate recalls to the user level, and return all products to the place of purchase.
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.
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/safety/recalls-market-withdrawals-safety-alerts/resource-recovery-trading-llcissues-nationwide-recall-hand-sanitizer-due-potential-presence-methanol
Source: FDA
Brand name: Resource Recover & Trading, LLC
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol subpotency ethyl alcohol
FDA Recall date: July 27, 2020
Recall details: RESOURCE RECOVERY & TRADING LLC, is voluntarily recalling all the lots manufactured by MXL Comercial S.A. de C.V. of Hand Sanitizer with the next information: HAND SANITIZER 70% Ethyl Alcohol Disinfectant Gel, packaged in 6.7 FL Oz. (200 ml) bottles, UPC 650240026020 and HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) liter plastic containers, UPC 37710600013 to the consumer level. The products are being recalled due to the potential presence of undeclared methanol (wood alcohol) and subpotency ethyl alcohol.
Risk Statement: The main concern with the use of hand sanitizer that is sub-potent for ethyl alcohol is the potential for decreased bactericidal and virucidal activity. Adverse health consequences can be related to increased infections. In addition substantial, undeclared methanol exposure, which has inferior antiseptic properties compared to ethanol, 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, RESOURCE RECOVERY & TRADING LLC has not received any reports of adverse events related to this recall. The product is used as a hand sanitizer to decrease germs when soap and water is not available and is packaged in 200 ml plastic bottles and 20 liter plastic containers. The product can be identified by the label attached. The product was distribution between June 10, 2020 and June 20, 2020 in the states of Alabama and Georgia.
RESOURCE RECOVERY & TRADING LLC is notifying its distributors and customers by phone calls and emails and is arranging for return and destruction of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using products, initiate recalls to the user level, and return all products to the place of purchase.
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.
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/safety/recalls-market-withdrawals-safety-alerts/resource-recovery-trading-llcissues-nationwide-recall-hand-sanitizer-due-potential-presence-methanol
Source: FDA