openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 7
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
6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. of Lot 142017
App-derived interpretation
Potency or specification failurereason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Code information
Lot #: 142017 Exp. Date 06/22
Distribution pattern
Distributed nationwide with the United States
drug · product 2 of 7
CTx7 Kit, contains one tube 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 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
3 single tubes of lot 192107 and 3 single tubes of 192108
App-derived interpretation
Potency or specification failurereason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Code information
Lot #: 192107 and lot 192108 Exp. Date 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Distribution pattern
Distributed nationwide with the United States
drug · product 3 of 7
CTx21 Kit, contains three tubes 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 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
180 single tube of lot 272109 and 180 single tube count of lot 272110
App-derived interpretation
Potency or specification failurereason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Code information
Lot #: 272109, 272110 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Distribution pattern
Distributed nationwide with the United States
drug · product 4 of 7
CTx26 Kit, contains three tubes 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 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
225 single tube of lot 31217 and 99 single tube of 312108
App-derived interpretation
Potency or specification failurereason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Code information
Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Distribution pattern
Distributed nationwide with the United States
drug · product 5 of 7
CTx36 Kit, contains three tubes 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 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
8 single tubes of lot 492106 and 50 single tubes of lot 492107
App-derived interpretation
Potency or specification failurereason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Code information
Lot #: 492106, 492107 Exp. Date 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017).
Distribution pattern
Distributed nationwide with the United States
drug · product 7 of 7
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.
