Drug product
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
D-0376-2015
Product summary
- Event
- Event 70261
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19,728 tubes
- Official record key
drug-enforcement:D-0376-2015
Official wording
Reason: 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..
Code information: Product Code: 12115SM, Lot # 30131
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing