Reported Feb 2, 2022 · Terminated

CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC:…

Dental Alliance Holdings LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dental Alliance Holdings LLC · 812 Water Ave Ne · Albany, OR · 97321-3074

Is this the product you have?

  • CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2
  • oz (57 g) Rx only NDC61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle
Lot codes and dates
  • Lot #: 272109, 272110 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Amount recalled
180 single tube of lot 272109 and 180 single tube count of lot 272110

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 11, 2022 · Data as of Sep 19, 5:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.