Z-0476-2016 Class II Terminated
FDA device recall Z-0476-2016 was initiated by Rainbow Specialty & Health Products on November 18, 2015 and is designated Class II. 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. The recall status is terminated (terminated May 2, 2016). Affected quantity: 2775.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2015
- Initiation Date
- November 18, 2015
- Termination Date
- May 2, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2775
Product Description
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
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.
Distribution Pattern
Nationwide. No foreign, govt/VA/military consignees.
Code Information
Lot-14317: Exp-052016; Lot-15007: Exp-102016, Lot-15140, Exp-122016