FDA MedWatch - Hand Sanitizer Packaged by American Screening:

U.S. Food and Drug Administration sent this bulletin at 11/22/2021 01:27 PM EST

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Hand Sanitizer Packaged by American Screening: Recall - Resemble Water Bottles Posing a Risk of Consumption

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: American Screening is recalling 153,336 units of hand sanitizer, containing 70% ethyl alcohol gel, because the hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption.

The affected hand sanitizer lots include the following expiration dates of 5/21/2022 and 05/24/2022 for black capped bottles and no lot numbers or expiration dates for clear capped bottles. The product can be identified by its shape (small water bottle), with a black flip top cap or clear cap with blue pouring spout with the weight of measure of eight (8) ounces/237mL, UPC 8 4005051579 2.

Risk Statement: Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects.

To date, American Screening has not received any reports of adverse events related to this recall.

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

BACKGROUND: The product being recalled is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available.

RECOMMENDATIONS:

Consumers that have the recalled hand sanitizer should stop using it and return to place of purchase or discard it.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to ingesting the recalled hand sanitizer.

Health professionals and consumers 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.

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