FDA Recall D-0098-2021

ASHTEL STUDIOS, INC. · Ontario, CA

Class I — life-threatening Terminated 1232 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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 / code: All lots codes within expiry

Quantity: N/A

Reason for recall

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

Recall record

Recall number: D-0098-2021
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Pouches of .84 oz.hand sanitizer were distributed to the following states: CA, IL, and Ontario Canada
Recall initiated: 2020-10-01
Classified by FDA Center: 2020-11-17
FDA published: 2020-10-21
Terminated: 2024-02-15
Recalling firm: ASHTEL STUDIOS, INC.
Firm location: Ontario, CA

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