Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw...
FDA Drug Recall #D-0098-2021 — Class I — October 1, 2020
Recall Summary
| Recall Number | D-0098-2021 |
| Classification | Class I — Serious risk |
| Date Initiated | October 1, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ASHTEL STUDIOS, INC. |
| Location | Ontario, CA |
| Product Type | Drugs |
| Quantity | N/A |
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
Reason for Recall
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Distribution Pattern
Pouches of .84 oz.hand sanitizer were distributed to the following states: CA, IL, and Ontario Canada
Lot / Code Information
All lots codes within expiry
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.