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Recall Observatory FDA recall evidence

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

December 19, 2014

Class III

Product summary

Firm
3M Company/3m Espe Dental Products
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

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing