Reported Dec 30, 2015 · Terminated

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

Rainbow Specialty & Health Products

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Rainbow Specialty & Health Products · 3400 14th Ave, Unit #28 · Markham, N/A · N/A

Is this the product you have?

  • Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only
  • Active IngredientsA.S.A. (Acetylsalicylic Acid) + Eugenol
Lot codes and dates
  • Lot-14317Exp-052016
  • Lot-15007
    • Exp-102016
    • Lot-15140
    • Exp-122016
Amount recalled
2775

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • VA

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 2, 2016 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.