Drug product
hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-pack overwrap UPC 8 19156 02349 4, UPC 10819156023491 case; in the variety 3-pack of Strawberry + Unicorn + Grape UPC 8 19156 02332 6, UPC 10819156023323 case; and in a 24-count Toothpaste Floorstand, UPC 819156020684 (case).
D-1084-2023
Product summary
- Event
- Event 92835
- Status
- Terminated
- Classification
- Class II
- Quantity
- 182,046 tubes
- Official record key
drug-enforcement:D-1084-2023
Official wording
Reason: Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.
Code information: Lot #: 004287, 2267USA94A, 2271USA94A, EXP 08/2024; 3053USA94A, Exp 01/2025; 3156USA94A, 3157USA94A, EXP 05/2025
Distribution pattern: Nationwide in the USSA
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up