US FDA: Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to The Potential Presence of Undeclared Methanol (Wood Alcohol): Updated August 7, 2020 – Quamed


Company Announcement Date: August 09, 2020 FDA Publish Date: August 09, 2020 Product Type: Drugs Reason for Announcement: Potential Methanol Contamination Company Name: Soluciones Cosmeticas Brand Name: Bersih Product Description: Hand Sanitizer Gel

Company Announcement

Soluciones Cosméticas voluntary recalled all lots of Bersih Hand Sanitizer Gel Fragrance Free sold in 16.9 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). This release provides additional information about the packaging for the recalled products.

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 Soluciones Cosméticas has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer and is packaged in 16.9 ounce plastic clear bottles with blue tops or green tops with UPC Codes 816822026667 or 7503007103178. The lot numbers range from 0100K01 to 0148K01. This product was distributed nationwide to wholesale distributors and retailers.

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