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Class III: unlikely to cause harmTerminated

Colgate Palmolive PreviDent 5000 ppm Recall

PreviDent 5000 ppm, DRY MOUTH, 1

Colgate Palmolive Co · New York, NY

Risk level
Class III
Reported by FDA
Mar 22, 2017
Recall ID
D-0521-2017
Check your lot numberHow we source this data

Summary

Colgate Palmolive recalled PreviDent 5000 ppm starting Feb 13, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0521-2017 on Mar 22, 2017. Reason: Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lots: 6350US561G, 6350US562G, 6351US561G, 6351US562G

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0521-2017
Classification
Class III
Status
Terminated
Recall initiated
Feb 13, 2017
FDA report date
Mar 22, 2017
Quantity
14,656 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Colgate Palmolive Co

Original FDA data

Every field from FDA enforcement report D-0521-2017, exactly as published.

Show all FDA fields
City
New York
State
NY
Status
Terminated
Country
United States
Event ID
76516
Address
300 Park Ave
Address (line 2)
Attn: Anthony Cavaliere
Code information
Lots: 6350US561G, 6350US562G, 6351US561G, 6351US562G
Postal code
10022-7402
Report date
Mar 22, 2017
Product type
Drugs
Recall number
D-0521-2017
Classification
Class III
Recalling firm
Colgate Palmolive Co
Product quantity
14,656 bottles
Termination date
Jun 13, 2017
Reason for recall
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Feb 13, 2017
Initial firm notification
Letter
Center classification date
Mar 15, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0521-2017, published Mar 22, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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