D-0521-2017 Class III Terminated
FDA drug recall D-0521-2017 was initiated by Colgate Palmolive Co on Feb 13, 2017 and is designated Class III. Reason for recall: Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. The recall status is terminated (terminated Jun 13, 2017). Affected quantity: 14,656 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 22, 2017
- Initiation Date
- Feb 13, 2017
- Termination Date
- Jun 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,656 bottles
Product Description
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
Reason for Recall
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Distribution Pattern
Nationwide
Code Information
Lots: 6350US561G, 6350US562G, 6351US561G, 6351US562G
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0521-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026