Home / Recalls / Rainbow Specialty & Health Products / Z-0477-2016

Z-0477-2016 Class II Terminated

Recalled by Rainbow Specialty & Health Products — Markham, N/A

Recall Details

Product Type: Devices
Report Date: December 30, 2015
Initiation Date: November 18, 2015
Termination Date: May 2, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 150

Product Description

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

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.

Distribution Pattern

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

Code Information

Lot - 5012, Exp-102016