Home / Recalls / Rainbow Specialty & Health Products / Z-0476-2016

Z-0476-2016 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: 2775

Product Description

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

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-14317: Exp-052016; Lot-15007: Exp-102016, Lot-15140, Exp-122016