Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0476-2016 — Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol

U.S. FDA — Device Enforcement · Canada · 2015-11-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0476-2016
Date of alert
2015-11-18
Country / jurisdiction
Canada
Risk level
Class II
Risk type
recall
Brand
Rainbow Specialty & Health Products
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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