Reported Dec 30, 2015 · Terminated
Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
Rainbow Specialty & Health Products
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: Rainbow Specialty & Health Products · 3400 14th Ave, Unit #28 · Markham, N/A · N/A
Is this the product you have?
- Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only
- Active IngredientsEugenol Oil
- Lot codes and dates
Lot - 5012Exp-102016
- Amount recalled
- 150
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- VA
Why it was recalled
Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components.
This product could cause temporary or reversible health problems — stop using it.
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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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