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Safety Report: Smart Care Hand sanitizer packaged in 0.84 oz. pouches - recalled due to product is packaged in containers resembling a food and drink pouch, United States

3 years ago •source fda.gov

Recall notice

Smart Care Hand sanitizer packaged in 0.84 oz. pouches - recalled due to product is packaged in containers resembling a food and drink pouch photo #1

United States

Company name: Ashtel Studios
Brand name: Smart Care
Product recalled: Hand sanitizer packaged in 0.84 oz. pouches
Reason of the recall: Product is packaged in containers resembling a food and drink pouch
FDA Recall date: October 02, 2020
Recall details: Company Announcement Ashtel Studios has announced a voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children’s characters listed in the table below to the consumer level.

The products are being recalled because they are packaged in containers resembling food and drink pouch. The recall does not affect any other Hand Sanitizer products from Ashtel Studios.

Product Size NDC
PAW Patrol Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-042-01
JoJo Siwa Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-044-01
Hot Wheels Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-045-01
Barbie Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-046-01
Trolls Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-047-01
Minions Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-043-01

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. Ashtel Studios has received no reports of adverse reactions.

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 0.84 oz pouches. The product can be identified by examples of the products pictured below. Product was distributed to selected retailers in the United States and Canada.

Ashtel Studios has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. While the product is not available for purchase, if a consumer has product which is being recalled they are advised to destroy it immediately.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ashtel-studios-issues-voluntary-recall-licensed-hand-sanitizers-packaged-084-fluid-ounce-pouches-due
Source: FDA

#drugs #handsanitizer #us

321

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