Rainbow Specialty & Health Products: Medical Device Recall in 2015 - (Recall #: Z-0477-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 18, 2015

Date Posted: December 30, 2015

Recall Number: Z-0477-2016

Event ID: 72726

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.

Status: Terminated

Product Quantity: 150

Code Information:

Lot - 5012, Exp-102016

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated