Recall Z-0477-2016 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Rainbow Specialty & Health Products
Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
| Date | Nov 18, 2015 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.