Why it was recalled
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
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.
Lot numbers, UPCs & expiration codes
Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Where it was sold
Distributed nationwide with the United States
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-0456-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 3, 2021
- FDA report date
- Feb 2, 2022
- Quantity
- 225 single tube of lot 31217 and 99 single tube of 312108
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dental Alliance Holdings LLC
Original FDA data
Every field from FDA enforcement report D-0456-2022, exactly as published.
Show all FDA fields
- City
- Albany
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 89152
- Address
- 812 Water Ave Ne
- Code information
- Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
- Postal code
- 97321-3074
- Report date
- Feb 2, 2022
- Product type
- Drugs
- Recall number
- D-0456-2022
- Classification
- Class III
- Recalling firm
- Dental Alliance Holdings LLC
- Product quantity
- 225 single tube of lot 31217 and 99 single tube of 312108
- Termination date
- Aug 11, 2022
- Reason for recall
- Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Distributed nationwide with the United States
- Recall initiation date
- Dec 3, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 26, 2022