The Recall Desk

FDA (Devices) recall action 72726

Rainbow Specialty & Health Products recalled 2 products on 2015-12-30

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-12-30
Critical
0
Units
2,925

Why these products were recalled

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 agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2015-12-30

    Dental Dressing Recall Due to Missing Drug Component Percentages

    Rainbow Specialty & Health Products is recalling Dressol-X and Dressit-X dental dressings because the labels do not list the percentage of drug components.

    Product
    Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-12-30

    Dental Dressing Recall for Missing Drug Component Percentages

    Rainbow Specialty & Health Products is recalling Dressit-X dental dressings because the labeling does not list the percentage of drug components.

    Product
    Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
    Category
    Distribution
    0 states