CLASS II Drug recall · Reported 2 Feb 2022 · FDA Enforcement Report
CSF Otic Insufflation Capsule recalled by Edge Pharma
Edge Pharma is recalling CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic, distributed nationwide in the US. The recall was initiated on 6 Dec 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0431-2022
- FDA event ID
- 89172
- Recalling firm
- Edge Pharma, Colchester, VT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Dec 2021
- FDA classified
- 24 Jan 2022
- Reported
- 2 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 6 Dec 2021 | Recall initiated by company | |
| 24 Jan 2022 | Classified by FDA | +49 days |
| 2 Feb 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
nationwide
Questions about this recall
Is CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic recalled?
Yes. Edge Pharma recalled CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic on 6 Dec 2021. The recall is Class II and its status is Terminated. Recall number D-0431-2022.
Why was it recalled?
CGMP Deviations
Which lots are affected?
10-2021-27@8 01-25-2022
Where was it sold?
nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Edge Pharma
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|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCl, Sterile Solution for Injection, (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Tetracaine HCl Nasal Solution recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Methotrexate, USP, Sterile Solution for Injection (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Ceftazidime, Sterile Ophthalmic Solution for Injection recalled | Edge Pharma | Sterility | Nationwide |
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