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Class I: serious health riskTerminated

Ashtel Studios Smart Care HAND SANITIZER Recall

Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0

ASHTEL STUDIOS, INC. · Ontario, CA

Risk level
Class I
Reported by FDA
Oct 21, 2020
Recall ID
D-0098-2021
Check your lot numberHow we source this data

Summary

Ashtel Studios recalled Smart Care HAND SANITIZER starting Oct 1, 2020. The FDA classified it as Class I (serious health risk) and published enforcement report D-0098-2021 on Oct 21, 2020. Reason: Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches. Status: Terminated.

Why it was recalled

Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches

Product description

Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144, UPC 8 50016 92317 2, NDC 70108-045-01); d) Barbie (Item #: 92318-144, UPC 8 50016 92318 9, NDC 70108-046-01); e) Trolls (Item #: 92322-144, UPC 8 50016 92322 6, NDC 70108-047-01); and f) Minions (Item #: 92319-144, UPC 8 50016 92319 6, NDC 70108-043-01); Distributed by Ashtel Studios Inc., Ontario, CA 91761

Lot numbers, UPCs & expiration codes

All lots codes within expiry

Where it was sold

Pouches of .84 oz.hand sanitizer were distributed to the following states: CA, IL, and Ontario Canada

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0098-2021
Classification
Class I
Status
Terminated
Recall initiated
Oct 1, 2020
FDA report date
Oct 21, 2020
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
ASHTEL STUDIOS, INC.

Original FDA data

Every field from FDA enforcement report D-0098-2021, exactly as published.

Show all FDA fields
City
Ontario
State
CA
Status
Terminated
Country
United States
Event ID
86546
Address
1610 E Philadelphia St
Code information
All lots codes within expiry
Postal code
91761-5759
Report date
Oct 21, 2020
Product type
Drugs
Recall number
D-0098-2021
Classification
Class I
Recalling firm
ASHTEL STUDIOS, INC.
Termination date
Feb 15, 2024
Reason for recall
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Voluntary / mandated
Voluntary: Firm initiated
Product description
Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144, UPC 8 50016 92317 2, NDC 70108-045-01); d) Barbie (Item #: 92318-144, UPC 8 50016 92318 9, NDC 70108-046-01); e) Trolls (Item #: 92322-144, UPC 8 50016 92322 6, NDC 70108-047-01); and f) Minions (Item #: 92319-144, UPC 8 50016 92319 6, NDC 70108-043-01); Distributed by Ashtel Studios Inc., Ontario, CA 91761
Distribution pattern
Pouches of .84 oz.hand sanitizer were distributed to the following states: CA, IL, and Ontario Canada
Recall initiation date
Oct 1, 2020
Initial firm notification
Press Release
Center classification date
Nov 17, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0098-2021, published Oct 21, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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