FDA Medical Device Recalls (openFDA)
Rainbow Specialty & Health Products: Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
- Recall number
- Z-0477-2016
- Recalling firm
- Rainbow Specialty & Health Products
- Product
- Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
- Status
- Terminated
- Initiated
- 2015-11-18
- Posted
- not on file
- Terminated
- 2016-05-02
- Reason
- 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
- 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
- 150
- Distribution
- Nationwide. No foreign, govt/VA/military consignees.
- Lot, serial or model codes
- Lot - 5012, Exp-102016
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDY
- Firm FEI
- 3002654714
- Firm city
- Markham
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28