FDA-Device2015-12-30Class II
Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
Rainbow Specialty & Health Products
Hazard
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.
Sold states
Nationwide. No foreign, govt/VA/military consignees.
Affected count
150
Manufactured in
3400 14th Ave, Unit #28, N/A, Markham, N/A, Canada
Products
Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0477-2016Don't want to check this manually?
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