The Recall Desk

FDA (Drugs) recall action 89152

Dental Alliance Holdings LLC recalled 7 products on 2022-02-02

The FDA (Drugs) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2022-02-02
Critical
0
Units
—

Why these products were recalled

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

The agency’s own wording, quoted from the enforcement report.

1–7 of 7

  • ModerateFDA (Drugs)··2022-02-02

    CTx7 Kit Recalled for Subpotent Sodium Fluoride Content

    The FDA is recalling CTx7 Kits distributed nationwide because the product contains less sodium fluoride than stated on the label.

    Product
    CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-02

    CariFree CTx4 Gel 5000 Subpotent Sodium Fluoride Recall

    Dental Alliance Holdings LLC is recalling CariFree CTx4 Gel 5000 fluoride gel tubes because they contain less sodium fluoride than stated on the label. The affected product is CTx12 5000 Kit lot 142017.

    Product
    CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-02

    CariFree CTx4 Gel 5000 Sample Boxes Recalled for Subpotent Fluoride

    CariFree sample boxes containing CTx4 Gel 5000 are being recalled because the product contains less Sodium Fluoride than stated on the label. Affected lots are 492106 and 492107, distributed nationwide.

    Product
    CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-02

    CTx21 Kit Dental Products Recalled for Subpotent Sodium Fluoride Content

    Dental Alliance Holdings LLC is recalling the CTx21 Kit because the product contains less sodium fluoride than stated on the label. Affected lots were distributed nationwide.

    Product
    CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2022-02-02

    CariFree CTx4 GEL 5000 Recalled for Subpotent Fluoride Content

    CariFree CTx4 GEL 5000 (Lot 142017) contains less sodium fluoride than stated on the label. The product is being recalled and consumers should contact their healthcare provider with questions.

    Product
    CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-02

    CariFree CTx36 Kit recalled for subpotent fluoride content

    Dental Alliance Holdings LLC is recalling the CTx36 Kit because it contains less sodium fluoride than stated on the product label. Affected patients should contact their dentist.

    Product
    CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-02-02

    CariFree CTx26 Kit Recalled for Subpotent Sodium Fluoride Content

    Dental Alliance Holdings LLC is recalling the CTx26 Kit because it contains less sodium fluoride than listed on the product label. Affected consumers should contact their dentist or healthcare provider.

    Product
    CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4f
    Category
    Distribution
    0 states