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Terminated

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

FDA Recall Z-0477-2016 · Posted None

Recalling FirmRainbow Specialty & Health Products
Recall StatusTerminated
Product CodeGDY
Date Initiated2015-11-18
Date Terminated2016-05-02
Product Quantity150

Reason for Recall

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.

Firm Action

Consignees have been made aware of the recall by FAX, e-mail and via telephone calls on 11/18/2015. Requested that distributors contact their clients, by telephone initially and then by email with written correspondence requesting them to recall the product from their clients.

Root Cause

Labeling design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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