Class III
Terminated
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.
This recall has been terminated (originally issued February 2, 2022).
- Company
- Dental Alliance Holdings Llc
- Recall Initiated
- December 3, 2021
- Posted
- February 2, 2022
- Recall Number
- D-0458-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8 single tubes of lot 492106 and 50 single tubes of lot 492107
- Firm Location
- Albany, OR, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Distribution
Distributed nationwide with the United States
Lot / Code Info
Lot #: 492106, 492107 Exp. Date 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017).
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