Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural In...
FDA Recall #D-0413-2022 — Class II — December 6, 2021
Product Description
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
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
309 vials
Distribution
nationwide
Code Information
09-2021-14@5 12/29/2021, 10/21/21 & 11-2021-04@2, 02/15/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated