Rainbow Specialty & Health Products recalls Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil

Recall date

November 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0477-2016

FDA classification

Class II

Brand / firm

Rainbow Specialty & Health Products

Sold / distributed

Nationwide. No foreign, govt/VA/military consignees.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil