3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04...

FDA Recall #D-0376-2015 — Class III — December 19, 2014

Recall #D-0376-2015 Date: December 19, 2014 Classification: Class III Status: Terminated

Product Description

3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M ESPE Dental Products, St. Paul, MN 55144

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..

Recalling Firm

3M Company/3m Espe Dental Products — Saint Paul, MN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

19,728 tubes

Distribution

Nationwide.

Code Information

Product Code: 12115SM, Lot # 30131

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated