Drug product
PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622
D-0521-2017
Product summary
- Event
- Event 76516
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,656 bottles
- Official record key
drug-enforcement:D-0521-2017
Official wording
Reason: Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Code information: Lots: 6350US561G, 6350US562G, 6351US561G, 6351US562G
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Label Mix up