FDA Device

Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol

Hazard

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.

What You Should Do

Remedy

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.

Products

Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
Brand
Rainbow Specialty & Health Products
UPC
Lot-14317: Exp-052016; Lot-15007: Exp-102016, Lot-15140, Exp-122016

Units Affected

2775