Dressol-X — Class II medical device recall Z-0476-2016
Terminated recall by Rainbow Specialty & Health Products, reported 2015-12-30, distributed nationwide. Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling
| Recall number | Z-0476-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rainbow Specialty & Health Products, Markham, N/A, Canada |
| Recall initiated | 2015-11-18 |
| Classified | 2015-12-23 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 2,775 |
| Reason classes | labeling |
| NDC | 11004-0502-40 |
| Lot numbers | 052016, 102016, 122016, 14317, 15007, 15140 |
Product
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0476-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.