Drug product
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2
D-0592-2025
Product summary
- Event
- Event 97382
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 46,692 tubes
- Official record key
drug-enforcement:D-0592-2025
Official wording
Reason: Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Code information: Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up