Device product
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
Z-0476-2016
Product summary
- Event
- Event 72726
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2775
- Official record key
device-enforcement:Z-0476-2016
Official wording
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.
Code information: Lot-14317: Exp-052016; Lot-15007: Exp-102016, Lot-15140, Exp-122016
Distribution pattern: Nationwide. No foreign, govt/VA/military consignees.
Derived failure modes
-
Unknown
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.