Device product

Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil

Z-0477-2016

November 18, 2015

Class II

Product summary

Firm: Rainbow Specialty & Health Products
Event: Event 72726
Status: Terminated
Classification: Class II
Quantity: 150
Official record key: device-enforcement:Z-0477-2016

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 - 5012, Exp-102016

Distribution pattern: Nationwide. No foreign, govt/VA/military consignees.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.