Ashtel Studios Issues Voluntary Recall of Licensed Hand Sanitizers

Ashtel Studios Issues Voluntary Recall of Licensed Hand Sanitizers Packaged in 0.84 Fluid Ounce Pouches Due to Misbranding Because They Resemble Food and Drink Container Pouches

Summary

Company Announcement Date: October 01, 2020

FDA Publish Date: October 02, 2020

Product Type: Drugs

Reason for Announcement: Product is packaged in containers resembling a food and drink pouch

Company Name: Ashtel Studios

Brand Name: Smart Care

Product Description: Hand sanitizer packaged in 0.84 oz. pouches

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.

Consumers with questions regarding this recall can contact Ashtel Studios, 866-Ashtel-1, 909-434-0911 (international) from 9:00 am-5:00 pm PST

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.

Company Contact Information:

Consumers:

Ashtel Studios

866-Ashtel-1, 909-434-0911 (international)

Media: Bill Southard/Southard Communications

908-812-4341

bill@southardinc.com

Product Photos

PAW Patrol Hand Sanitizer

JoJo Siwa Hand Sanitizer

Barbie Hand Sanitizer

Hot Wheels Hand Sanitizer

Trolls Hand Sanitizer

Minions Hand Sanitizer

From 1035 The BEAT:

RECALL: Six Smart Care Kids Hand Sanitizers

As the Coronavirus continues to spread throughout the United States and other countries, hand sanitizer is still one of the most sought after items. However officials have recently sent out warnings about certain kids hand sanitizers that have been recalled from the brand 'smart care. According to the Herald;

"The FDA claimed no problem with the actual hand sanitizer. It’s the combination of the pouches, kids likely being given the hand sanitizer as they head back to schools and children’s carelessness or curiosity, despite the packaging warning, Do Not Eat.

The FDA said, “Hand sanitizer products packaged in containers resembling food pouches commonly used for children’s applesauce and other pureed foods that present increased risk of accidental ingestion by children. An Ashtel spokesman told the Herald that the company took all of these products off the shelves in August when a parent brought up the potential problem. The FDA didn’t indicate that in its product status notation after adding the Smart Care sanitizers to the Do Not Use list on Sept. 24.”

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From Slash Gear:

Hand Sanitizer recalled because it looks like snack food for kids

The folks at Ashtel Studios made a design mistake. They saw an opportunity to make hand sanitizer fun for kids, but they took an unfortunate approach. It became clear some time after packaging and distribution began, this year, that Ashtel Studios hand sanitizer looked a little too much like “a food and drink pouch” for kids.

Imagine designing a package so delightful that your intended audience wants to eat or drink whatever’s inside. Now imagine that the packaging you’ve created will be used for a product that’s poisonous for humans.

In this article you’ll see images of the hand sanitizer packaging that’s been recalled. This includes the 0.84 FL. OZ (25 mL) size hand sanitizer product from Ashtel Studios, and no other hand sanitizer products from said company.

The collection includes several branded Smart Care hand sanitizer packages with licensed brands like Illumination’s Minions, DreamWorks’ Trolls, Mattel’s Barbie, Mattel’s Hot Wheels, Nickelodeon’s Jojo Siwa DREAMER, and Spin Masters’ Paw Patrol.

As it true of all hand sanitizer, this hand sanitizer was made for topical use – on human hands. If hand sanitizer is swallowed, it can result in alcohol toxicity, which the FDA reminds can have a range of symptoms. “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.”

NOTE: Heavy Machinery doesn’t just include forklifts and bulldozers. It includes any sort of mechanical vehicle or tool that you wouldn’t want to operate while you are, for example, falling asleep, or in a coma. Also, again, there’s a decent chance you will die if you ingest enough hand sanitizer, which is why the friendly snack-sized packaging for the hand sanitizer shown above is recalled right this minute.

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