Recall Z-0477-2016— Rainbow Specialty & Health Products
Class II · Terminated
Class II FDA medical device recall by Rainbow Specialty & Health Products, initiated 2015-11-18, terminated 2016-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil. 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..
- Recalling firm
- Rainbow Specialty & Health Products
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-18
- Terminated
- 2016-05-02
- Firm location
- Markham, N/A, Canada
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.