US Drug Recall Register
Class III · Low risk Terminated Initiated Feb 13, 2017 (10 years ago)

PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.

What was recalled

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

Recalling firm
Colgate Palmolive Co
NDC code
0126-0016-61
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0521-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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