United States
Company name: Broncolin S.A. de C.V
Brand name: Herbacil
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: July 28, 2020
Recall details: Broncolin S.A. de C.V is voluntarily recalling all lots of Herbacil Antiseptic Hand Sanitizer 70% Alcohol to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).
Risk Statement: Substantial methanol exposure "could 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 accidentally 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, Broncolin S.A. de C.V. has not received any reports of adverse events related to the product in question.
The product is an alcohol-based hand sanitizer used to reduce bacteria that potentially cause disease when soap and water are not available and is packaged in 4 bottle sizes; 4.22 fl. oz. (125ml), 8.4 fl. oz. (250 ml), 16.9 fl. oz. (500 ml) and 33.8 fl. oz. (1 Liter). It is a clear plastic bottle with a pump or squeeze cap. All package sizes are labeled with a blue label identifying INBC Trading LLC 4404 Merle Drive, Austin, TX 78745 as the Importer/Distributor (see attachments). Herbacil Antiseptic Hand Sanitizer 70% Alcohol was distributed by the importer/distributor between April 26, 2020 to May 18, 2020 , to wholesalers in Arizona, California, Florida, Georgia, Illinois, Maryland, New Jersey, New York, North Carolina, South Carolina, and Texas and further distributed Nationwide in the USA.
Broncolin S.A. de C.V via INBC Trading LLC is notifying all US customers by email and is arranging for the return of all recalled products. Consumers, distributors, and retailers that have recalled Herbacil hand sanitizer, should stop using and return 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
Source: FDA
