FDA-Drug2022-02-02Class II

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

Edge Pharma, LLC
Hazard

CGMP Deviations

Sold states
nationwide
Affected count
1055 bottles
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0431-2022

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