D-0376-2015 Class III Terminated
FDA drug recall D-0376-2015 was initiated by 3M Company/3m Espe Dental Products on December 19, 2014 and is designated Class III. 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.. The recall status is terminated (terminated April 14, 2015). Affected quantity: 19,728 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- January 28, 2015
- Initiation Date
- December 19, 2014
- Termination Date
- April 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,728 tubes
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..
Distribution Pattern
Nationwide.
Code Information
Product Code: 12115SM, Lot # 30131