Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single ...
FDA Recall #D-0307-2021 — Class III — December 22, 2020
Product Description
Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
60 syringes
Distribution
PA only
Code Information
Lot #: 10-2020-13@8, exp. date 12/03/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated