FDA-Drug2026-10-19Class II
ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-785-35, Item # 88785, UPC 8 10147 88785
Hazard
CGMP Deviations.
Sold states
US Nationwide.
Affected count
15,264 tubes
Manufactured in
Khasra No. 138, Raipur Industrial Area, Bhagwanpur, Haridwar, India
Products
ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-785-35, Item # 88785, UPC 8 10147 88785
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0069-2027More PRITAM INTERNATIONAL PRIVATE LIMITED recalls
- FDA-Drug2026-10-19Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-002-40, Item # 88047, UPC 8 10147 88047 8
- FDA-Drug2026-10-19Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-003-40, Item # 32731, UPC 8 50048 32731 3
- FDA-Drug2026-10-19Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-517-35, Item # 88517, UPC 8 10147 88517 6
- FDA-Drug2026-10-19evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3
- FDA-Drug2026-10-19Brush Buddies, Crayola Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-005-40, Item # 32732, UPC 8 50048 32732 0
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