Product: Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
Reason for recall: Lack of Assurance of Sterility
Recall initiated: 20211206
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated