Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption
- Company Name:
- American Screening LLC
- Brand Name:
- Product Description:
Company Announcement
FOR IMMEDIATE RELEASE – November 19, 2021 – American Screening LLC of Shreveport, Louisiana is voluntarily recalling 153,336 units of Hand Sanitizer, containing 70% ethyl alcohol gel to the consumer level. The hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption.
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. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute. To date, American Screening LLC has not received any reports of adverse events related to this recall.
The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in an eight ounce bottle. 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. The Hand Sanitizer was sold to customers & distributors Nationwide via the internet at americanscreeningcorp.com and/or in-house sales.
American Screening LLC is notifying its distributors and customers by mass email and is arranging for return of all recalled Hand Sanitizers.
Consumers & distributors that have this hand sanitizer which is being recalled should stop distribution/use and return to place of purchase or discard.
Consumers with questions regarding this recall can contact Wendy Laskowski by e-mailing [email protected] or call 318-606-6037 Monday–Friday, 8:00 am–5:00 pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to ingesting the hand sanitizer packaged in the 8 oz. water bottle style.
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.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
