Home / Recalls / Dental Alliance Holdings LLC / D-0456-2022

D-0456-2022 Class III Terminated

Recalled by Dental Alliance Holdings LLC — Albany, OR

Recall Details

Product Type
Drugs
Report Date
February 2, 2022
Initiation Date
December 3, 2021
Termination Date
August 11, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
225 single tube of lot 31217 and 99 single tube of 312108

Product Description

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 4fl.oz. Carifree CTx4 Treatment Rinse.

Reason for Recall

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

Distribution Pattern

Distributed nationwide with the United States

Code Information

Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)

Other recalls by Dental Alliance Holdings LLC

  • D-0454-2022 Class III — CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride (December 3, 2021)
  • D-0455-2022 Class III — CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium (December 3, 2021)
  • D-0457-2022 Class III — CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium F (December 3, 2021)
  • D-0458-2022 Class III — CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral (December 3, 2021)
  • D-0459-2022 Class III — CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% (December 3, 2021)
  • D-0453-2022 Class III — CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only ND (December 3, 2021)