Dental Dressing Recall for Missing Drug Component Percentages
Rainbow Specialty & Health Products is recalling Dressit-X dental dressings because the labeling does 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 the hazard is a minor labeling error regarding drug component percentages, which fits the criteria for moderate severity.
Plain-English summary
Rainbow Specialty & Health Products has initiated a field action for Dressit-X, a radiopaque dental dressing product. The recall is due to a labeling error where the product packaging does not currently list the percentage of drug components.
The affected product is Dressit-X, Radiopaque D-545, NDC 11004-545-40, intended for dental use only. The active ingredient is Eugenol Oil. The specific lot number is 5012, with an expiration date of 10/2016. The quantity involved is 150 units.
The product was distributed nationwide. There are no foreign, government, VA, or military consignees. Consumers and dental professionals should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
- Manufacturer
- Rainbow Specialty & Health Products
- Category
- Drug — Dental Dressing
- Hazard
- Affected units
- 150
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 (2)
- Lot - 5012
- Exp-102016
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 Due to Missing Drug Component Percentages
FDA (Devices) · 2015-12-30
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