FDA Recalls CSF Otic Insufflation Capsule for CGMP Deviations
Edge Pharma, LLC is recalling 1055 bottles of CSF Otic Insufflation Capsule containing Sulfacetamide Sodium, Ciprofloxacin, and Amphotericin B nationwide due to CGMP manufacturing deviations.
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 manufacturing deviations without reported illness or injury. The source text does not indicate hospitalization, deaths, or any harm events, making this a precautionary manufacturing-quality recall typical of Class II severity.
Plain-English summary
Edge Pharma, LLC is recalling CSF Otic Insufflation Capsule (Sulfacetamide Sodium/Ciprofloxacin/Amphotericin B Otic Powder, 50mg/30mg/5mg, 5 count bottle, NDC 05446-1633-05) distributed nationwide. The recall affects 1055 bottles and was initiated on December 6, 2021.
The reason for recall is Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. This is a voluntary recall initiated by the firm and was communicated via press release.
Consumers who have received this product should discontinue use and consult with their healthcare provider regarding their treatment options. The recall was terminated on June 7, 2023.
The recalled product
- 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
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Otic Powder
- 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)
- 10-2021-27@8 01-25-2022
Distribution
Distributed nationwide across the United States.
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