Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution...
FDA Recall #D-0404-2022 — Class II — December 6, 2021
Product Description
Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18
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
1202 syringes
Distribution
nationwide
Code Information
10-2021-26@3 12/04/2021 11-2021-09@1 12/23/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated