CSF Otic Insufflation Capsule — Class II drug recall D-0431-2022
Terminated recall by Edge Pharma, LLC, reported 2022-02-02, distributed nationwide. CGMP Deviations
| Recall number | D-0431-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edge Pharma, LLC, Colchester, VT, United States |
| Recall initiated | 2021-12-06 |
| Classified | 2022-01-24 |
| Reported by FDA | 2022-02-02 |
| Terminated | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,055 bottles |
| Reason classes | cgmp |
| NDC | 05446-1633-05 |
Product
CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Otic Use with Insufflator, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1633-05
Reason for recall
CGMP Deviations
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/D-0431-2022. 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.