Key Takeaway

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 by 3M Company/3m Espe Dental Products was recalled on December 19, 2014. The hazard: 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..

FDA Drug Class III Terminated

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

Recalled: December 19, 2014 ~19,728 tubes units affected D-0376-2015

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

Hazard / 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..

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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

Drugs

Company Information

3M Company/3m Espe Dental Products

Saint Paul, MN, United States

View all 1 recalls by 3M Company/3m Espe Dental Products →

Distribution

Nationwide.

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.