CSF-HC Otic Insufflation Capsule recalled over manufacturing violations
- Recall date
- December 6, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Edge Pharma, LLC recalls CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 3…
- Recall number
- D-0432-2022
- FDA classification
- Class II
- Brand / firm
- Edge Pharma, LLC
- Sold / distributed
- nationwide
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01
Get recall alerts
Free email alert whenever Edge Pharma, LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Edge Pharma, LLC