FDA MedWatch - Hand Sanitizer Isopropyl Alcohol Antiseptic 75% by Tennessee Technical Coatings Corp:

U.S. Food and Drug Administration sent this bulletin at 03/08/2022 03:00 PM EST

If your email program has trouble displaying this email, view as a webpage.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Hand Sanitizer Isopropyl Alcohol Antiseptic 75% by Tennessee Technical Coatings Corp: Recall - Due to Presence of Methanol

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: Tennessee Technical Coatings Corp. is recalling all lots of HAND SANITIZER Isopropyl Alcohol Antiseptic 75% because FDA analysis has found the product to contain methanol.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache blurred vision, coma, seizures, permanent blindness, permanent damage to the central 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, Tennessee Technical Coatings Corp. has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available.

RECOMMENDATIONS:

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.
Consumers/distributors/retailers that have HAND SANITIZER Isopropyl Alcohol Antiseptic 75% which is being recalled should stop using, return to place of purchase/contact their doctor.
Consumers with questions regarding this recall can contact the company.

Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions | Unsubscribe All | Help