Z-0477-2016Class II

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

Name: Z-0477-2016 Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
Creator: Rainbow Specialty & Health Products
Published: 2015-11-18
License: https://open.fda.gov/license/

Rainbow Specialty & Health Products / initiated 2015-11-18 / Terminated / root cause: labeling and UDI

FDA source

Rainbow Specialty & Health Products began a recall of Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil on 2015-11-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0477-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-18
Posted: 2015-12-23
Terminated: 2016-05-02
Recalling firm: Rainbow Specialty & Health Products
Product: Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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.
Quantity in commerce: 150
Distribution: Nationwide. No foreign, govt/VA/military consignees.
Product codes and lots: Lot - 5012, Exp-102016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0477-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0476-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23
Z-0477-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23

Product code GDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)