Why it was recalled
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 492106, 492107 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-0458-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 3, 2021
- FDA report date
- Feb 2, 2022
- Quantity
- 8 single tubes of lot 492106 and 50 single tubes of lot 492107
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dental Alliance Holdings LLC
Original FDA data
Every field from FDA enforcement report D-0458-2022, 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 #: 492106, 492107 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-0458-2022
- Classification
- Class III
- Recalling firm
- Dental Alliance Holdings LLC
- Product quantity
- 8 single tubes of lot 492106 and 50 single tubes of lot 492107
- 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
- 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.
- Distribution pattern
- Distributed nationwide with the United States
- Recall initiation date
- Dec 3, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 26, 2022