Home / Recalls / Dental Alliance Holdings LLC / D-0457-2022

D-0457-2022 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
90 single tubes of 352110 and 315 single tubes of 352111

Product Description

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.

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 #: 352110, 352111 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-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)
  • D-0456-2022 Class III — CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium F (December 3, 2021)