Reported Jun 19, 2024 · Ongoing
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Young Dental Manufacturing I, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Young Dental Manufacturing I, LLC · 13705 Shoreline Ct E · Earth City, MO · 63045-1202
Is this the product you have?
- Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
- Lot codes and dates
- Unique Device Identifier (UDI)100889813036273
- Lot248607; Part number 040032 is the Young Dental part number. The Darby Dental Part Number (that is on the label) is 9518637
- Amount recalled
- 534 units
Where it was sold
- Nationwide
- TN
Why it was recalled
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
This product could cause temporary or reversible health problems — stop using it.
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