Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection,...
FDA Recall #D-0415-2022 — Class II — December 6, 2021
Product Description
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 for Recall
Lack of Assurance of Sterility
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3747 syringes
Distribution
nationwide
Code Information
09-2021-09@4 12/22/2021 & 10-2021-14@1 01/26/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated