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Class II Recall
Edge Pharma, LLC
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
Reason
CGMP Deviations
Classification
Class II
Status
Terminated
Lot
10-2021-05@9 01-01-2022 & 10-2021-28@4 01-26-2022
Date
2022-02-02
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.