Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per ...
FDA Recall #D-0396-2022 — Class II — December 6, 2021
Product Description
Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
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
8140 syringes
Distribution
nationwide
Code Information
10-2021-25@4 12/08/2021 11-2021-08@6 12/22/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated