FDA Drug Class III — Least Serious

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 Distributed in 12-pk/cases

Hazard

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

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Products

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 Distributed in 12-pk/cases
Brand
Dental Alliance Holdings LLC
UPC
Lot #: 142017 Exp. Date 06/22

Units Affected

6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. of Lot 142017

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