FDA Drug Class III — Least Serious

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.

Hazard

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

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Products

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.
Brand
Dental Alliance Holdings LLC
UPC
Lot #: 142017, exp. Date 06/22

Units Affected

360 individual tubes of lot 142017.

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