October 2020 FDA Recall Drug by Ashtel Studios, Inc.
D-0098-2021 - Labeling

This Class I drug recall was voluntarily initiated by Ashtel Studios, Inc. on October 1, 2020 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Pouches of .84 oz.hand sanitizer were distributed to the following states: CA, IL, and Ontario Canada and the recall is currently terminated.

Recall Number: D-0098-2021

Reason for Recall
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Initiated
10-01-2020
Reported
10-21-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ASHTEL STUDIOS, INC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Pouches of .84 oz.hand sanitizer were distributed to the following states: CA, IL, and Ontario Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-15-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# All lots codes within expiry