Class II Recall

Edge Pharma, LLC

Product
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
Reason
Lack of Assurance of Sterility
Classification
Class II
Status
Terminated
Lot
09-2021-09@4 12/22/2021 & 10-2021-14@1 01/26/2022
Date
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.