Date Initiated by Firm | November 18, 2015 |
Create Date | December 23, 2015 |
Recall Status1 |
Terminated 3 on May 02, 2016 |
Recall Number | Z-0476-2016 |
Recall Event ID |
72726 |
Product Classification |
Gauze/sponge, internal, x-ray detectable - Product Code GDY
|
Product | Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol |
Code Information |
Lot-14317: Exp-052016; Lot-15007: Exp-102016, Lot-15140, Exp-122016 |
Recalling Firm/ Manufacturer |
Rainbow Specialty & Health Products 3400 14th Ave, Unit #28 Markham Canada
|
Manufacturer 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. |
FDA Determined Cause 2 | 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 | 2775 |
Distribution | Nationwide. No foreign, govt/VA/military consignees. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|