The Recall Desk
ModerateFDA (Drugs)·D-0432-2022·Announced 2022-02-02

CSF-HC Otic Powder Drug Recalled for Manufacturing Deviations

Edge Pharma, LLC is recalling CSF-HC Otic Insufflation Capsule nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 440 cartons of this antibiotic and steroid combination powder.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for CGMP deviations, a manufacturing/quality control issue. The source text does not report any illnesses, injuries, or hospitalizations. Class II recalls without reported adverse events and without high-risk pathogens or allergen issues typically fall in the Moderate range.

Plain-English summary

Edge Pharma, LLC is recalling CSF-HC Otic Insufflation Capsule, containing Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder (50mg/30mg/25mg/5mg), distributed nationwide. The product is supplied in 5-count bottles, NDC 05446-1634-01, with a total of 440 cartons affected.

The recall was initiated on December 6, 2021, and classified as a Class II recall on January 24, 2022. The reason for recall is Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. This is a voluntary, firm-initiated recall announced via press release.

Consumers who have this product should stop using it and contact their healthcare provider. Patients currently using this medication should consult with their physician before discontinuing use or switching to an alternative treatment.

The recalled product

Product
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
Manufacturer
Edge Pharma, LLC
Category
Drug — Otic / Ear Medication
Hazard
  • manufacturing-deviation
  • cgmp-violation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 10-2021-05@9 01-01-2022 & 10-2021-28@4 01-26-2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category