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Safety Report: Bersih 手部消毒液凝胶-因潜在甲醇污染而召回, USA

4年前 source fda.gov

Recall notice

United States

Company name: Soluciones Cosmeticas
Brand name: Bersih
Product recalled: Hand Sanitizer Gel
Reason of the recall: Potential Methanol Contamination
FDA Recall date: July 14, 2020
Recall details: Soluciones Cosméticas is voluntarily recalling 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). To date Soluciones Cosméticas has not received reports of adverse events related to this recall.

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.

The product is used as a hand sanitizer and is packaged in 16.9 ounce plastic clear bottles with blue tops with UPC Code 816822026667. The lot numbers range from 0106K01 to 0148K01. This product was distributed nationwide to wholesale distributors and retailers.

Soluciones Cosméticas is notifying its distributors by voluntary recall letter and consumers via this press release. Consumers that have the product subject to this recall should stop using and either contact Soluciones Cosméticas per the below for disposal instructions or return it to the place of purchase. Consumers with questions regarding this recall can contact Soluciones Cosméticas at 866-912-8410 Monday through Friday 8am to 5pm Eastern Time or by email at bersihrecall6551@stericycle.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this 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 either online, by regular mail or by fax.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/soluciones-cosmeticas-issues-voluntary-nationwide-recall-bersih-hand-sanitizer-gel-due-potential

Source: FDA

#drugs #handsanitizer #unitedstates

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