Class II · Moderate risk
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Temperature Abuse
CSF Otic Insufflation Capsule
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDC
5446-1633-05
Compare with the code on your package — it is the most precise check available.
Drug: Ciprofloxacin Category: Antibiotic
- Recalling firm
- Edge Pharma, LLC
- NDC code
- 05446-1633-05
- Origin
- VT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0431-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ciprofloxacin recalls
See all
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution USP
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk
Ciprofloxacin Ophth Solution
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution USP
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk
Ciprofloxacin ophthalmic solution USP
Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Other recalls by Edge Pharma, LLC
All 2021 recalls
Class II · Moderate risk
Trypan Blue 0.03%
CGMP Deviations
Class II · Moderate risk
Vancomycin HCl Oral Solution
CGMP Deviations
Class II · Moderate risk
Tetracaine HCl Nasal Solution
CGMP Deviations
Class II · Moderate risk
Promethazine HCl Topical Ointment
CGMP Deviations
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