Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syrin...
FDA Recall #D-0395-2022 — Class II — December 6, 2021
Product Description
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
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
4465 syringes
Distribution
nationwide
Code Information
08-2021-27@3 12/09/2021 09-2021-24@1 01/06/2022 10-2021-14@2 01/31/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated