🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: November 18, 2015 Rainbow Specialty & Health Products Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot - 5012, Exp-102016
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Rainbow Specialty & Health Products
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot - 5012, Exp-102016

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0477-2016

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