Reported Feb 2, 2022 · Terminated
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral…
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?
- 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 Distributed in 12-pk/cases
- Lot codes and dates
- Lot #: 142017 Exp. Date 06/22
- Amount recalled
- 6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. of Lot 142017
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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