FDAClass IIDecember 30, 2015

Dressol-X recall: Labeling Error

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

Why was Dressol-X 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot-14317: Exp-052016; Lot-15007: Exp-102016, Lot-15140, Exp-122016

Product
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
Recalling firm
Rainbow Specialty & Health Products
Quantity
2775
Distribution
Nationwide. No foreign, govt/VA/military consignees.
Recall date
December 30, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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