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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding drug component percentages, which fits the rubric for moderate severity involving labeling issues without reported injuries.
Plain-English summary
Rainbow Specialty & Health Products has initiated a field action for Dressol-X and Dressit-X dental dressings. The recall is due to a labeling error where the product packaging does not currently list the percentage of the active drug components, which include Acetylsalicylic Acid (A.S.A.) and Eugenol.
The affected products are identified by NDC 11004-502-40 and are intended for dental use only. The recall covers 2,775 units distributed nationwide. Specific lots affected include Lot-14317 (Expiration 05/2016), Lot-15007 (Expiration 10/2016), and Lot-15140 (Expiration 12/2016). The distribution was limited to the United States, with no foreign, government, VA, or military consignees.
Consumers and dental professionals should stop using the affected products and contact Rainbow Specialty & Health Products for further instructions or a replacement. This action is a precautionary measure to ensure accurate labeling of drug components.
The recalled product
- Product
- Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
- Manufacturer
- Rainbow Specialty & Health Products
- Category
- Medical Device — Dental Dressing
- Hazard
- Affected units
- 2,775
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot-14317: Exp-052016
- Lot-15007: Exp-102016
- Lot-15140
- Exp-122016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Rainbow Specialty & Health Products under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Rainbow Specialty & Health Products
See all →- ModerateDental Dressing Recall for Missing Drug Component Percentages
FDA (Devices) · 2015-12-30
Same hazard · mis labeling
See all →- High
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