Elevated risk U.S. Food and Drug Administration

Smart Care Hand sanitizer packaged in 0.84 oz. pouches recall: Product is packaged in containers resembling a food and drink pouch

Recall published 6+ years ago

Product is packaged in containers resembling a food and drink pouch

Smart Care Prescription & OTC drugs — recalled prescription & otc drugsSmart Care Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Smart Care Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Smart Care Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Mislabelling or misbranding

This is a packaging mix-up rather than a safety failure in the food itself — the wrong label, lid or sleeve went onto the product.

What the notice says: Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
October 1, 2020
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Smart Care
Product type
Prescription & OTC drugs
Reports of harm
Ashtel Studios has received no reports of adverse reactions

Products covered by this recall

Hand sanitizer packaged in 0.84 oz. pouches

What the company announced

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

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

NDC number

On the carton and again on the bottle or blister label.

  • 70108-042-01
  • 70108-044-01
  • 70108-045-01
  • 70108-046-01
  • 70108-047-01
  • 70108-043-01

Package size

Match the net weight or the piece count on the front of the pack.

  • 0.84 oz
  • 0.84 FL. OZ
  • 25 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Smart Care — This is a packaging mix-up rather than a safety failure in the food itself — the wrong label, lid or sleeve went onto the product.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. Keep a photo of the mismatched label, which makes the refund conversation much shorter.
  3. Check the lot code on your pack — these mix-ups are usually confined to a short production window.
  4. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: While the product is not available for purchase, if a consumer has product which is being recalled they are advised to destroy it immediately.

Company contact: Ashtel Studios — Consumers: Ashtel Studios, 866-Ashtel-1, 909-434-0911 (international) — Media: Bill Southard/Southard Communications, 908-812-4341, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Smart Care prescription & otc drugs recalled?

Product is packaged in containers resembling a food and drink pouch Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

The notice says: While the product is not available for purchase, if a consumer has product which is being recalled they are advised to destroy it immediately.

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