Medek LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% because it contains methanol, or wood alcohol, and is sub-potent for ethanol, the correct type of alcohol that kills bacteria, according to the FDA. There have been no reports of adverse reactions about the use of this product receive by the company to date.
The Risk Statement on the recall notice states: 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. In addition, the use of sub-potent hand sanitizer products can have adverse health consequences related to lack of efficacy and increased risk of infections.
The recalled product is used as a hand sanitizer for hand washing when soap and water aren’t available. The recalled M Hand Sanitizer is packaged in a one gallon (128 ounce/3,785 mL) High density polyethylene (HDPE) plastic bottle. The NDC number is 75432-001-02.
This product was distributed directly to walk-in customers in Alamo, Texas, from April 17, 2020 to May 22, 2020. Medek is notifying customers and distributors by recall letter and customers through this press release. If you have this product, stop using it immediately. You can discard it according to your community’s hazardous waste disposal program, or take it back to the place of purchase for a refund.
If you have experienced any adverse effects using this product, see your doctor. Then report the issue to the FDA using the FDA’s MedWatch Adverse Event Reporting Program online, by fax, or by regular mail.
