Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
Class I - Dangerous 🏥 Medical Devices
Recalled: November 18, 2015 Rainbow Specialty & Health Products Infusion Pumps
Nationwide
What Should You Do?
- Check if you have this product: Lot-14317: Exp-052016; Lot-15007: Exp-102016, Lot-15140, Exp-122016
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
Product Codes/Lot Numbers:
Lot-14317: Exp-052016; Lot-15007: Exp-102016, Lot-15140, Exp-122016
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0476-2016
Related Recalls
Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
Rainbow Specialty & Health Products
Class I - Dangerous
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.