Recalls / Class III
Class IIID-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
- Brand name
- Prevident
- Generic name
- Sodium Fluoride
- Active ingredient
- Sodium Fluoride
- Route
- Dental
- NDC
- 0126-0016
- Affected lot / code info
- Lots: 6350US561G, 6350US562G, 6351US561G, 6351US562G
Why it was recalled
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Recalling firm
- Firm
- Colgate Palmolive Co
- Manufacturer
- Colgate Oral Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Park Ave, Attn: Anthony Cavaliere, New York, New York 10022-7402
Distribution
- Quantity
- 14,656 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-13
- FDA classified
- 2017-03-15
- Posted by FDA
- 2017-03-22
- Terminated
- 2017-06-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0521-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.