Drug 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
D-0431-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1055 bottles
- Official record key
drug-enforcement:D-0431-2022
Official wording
Reason: CGMP Deviations
Code information: 10-2021-27@8 01-25-2022
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations