FDA recall D-0521-2017

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-02-13

Report date

2017-03-22

Termination date

2017-06-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0521-2017