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Class III: unlikely to cause harmTerminated

3M ESPE Clinpro 5000 Recall

3M ESPE Clinpro 5000 (1

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

Risk level
Class III
Reported by FDA
Jan 28, 2015
Recall ID
D-0376-2015
Check your lot numberHow we source this data

Summary

3M Company/3m Espe Dental Products recalled 3M ESPE Clinpro 5000 starting Dec 19, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0376-2015 on Jan 28, 2015. 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.. Status: Terminated.

Why it was recalled

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..

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

Lot numbers, UPCs & expiration codes

Product Code: 12115SM, Lot # 30131

Where it was sold

Nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0376-2015
Classification
Class III
Status
Terminated
Recall initiated
Dec 19, 2014
FDA report date
Jan 28, 2015
Quantity
19,728 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
3M Company/3m Espe Dental Products

Original FDA data

Every field from FDA enforcement report D-0376-2015, exactly as published.

Show all FDA fields
City
Saint Paul
State
MN
Status
Terminated
Country
United States
Event ID
70261
Address
Bldg 0260-02a-11
Code information
Product Code: 12115SM, Lot # 30131
Postal code
55144-0001
Report date
Jan 28, 2015
Product type
Drugs
Recall number
D-0376-2015
Classification
Class III
Recalling firm
3M Company/3m Espe Dental Products
Product quantity
19,728 tubes
Termination date
Apr 14, 2015
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..
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide.
Recall initiation date
Dec 19, 2014
Initial firm notification
E-Mail
Center classification date
Jan 20, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0376-2015, published Jan 28, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

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