Edge Pharma, LLC recalls Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL p
Recalled February 2, 2022 · FDA recall D-0399-2022 · Edge Pharma
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
323 syringes
Sold at
nationwide
Description
Lack of Assurance of Sterility
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
Manufacturer(s)
Edge Pharma, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →