FDAFDA · Food and drugs·Recall number D-0459-2022
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.
Published February 2, 2022 · Recall initiated: December 3, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dental Alliance Holdings LLC
- Distributor
- Distributed nationwide with the United States
- Lot
- Lot #: 142017, exp. Date 06/22
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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