Class II · Moderate risk
J-TAN D PD Drops
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
3M ESPE Clinpro 5000
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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..
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
48878-3130-04
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Clinpro 5000 sodium fluoride NDC 48878-3130 |
5 mg/g | Paste, Dentifrice Oral |
Solventum US LLC | Rx |
- Recalling firm
- 3M Company/3m Espe Dental Products
- NDC code
- 48878-3130-04
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0376-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other labeling / mix-up recalls from 2014
All labeling / mix-up recalls
Class III · Low risk
BELVIQ¿ (Lorcaserin HCl)
Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
Class III · Low risk
Fluoxetine Capsules USP
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Class II · Moderate risk
Potassium Chloride Injection
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
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