Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 ...
FDA Recall #D-0397-2022 — Class II — December 6, 2021
Product Description
Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01
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
168 syringes
Distribution
nationwide
Code Information
09-2021-01@6 12/14/2021 & 10-2021-27@4 01/01/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated