Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.2...
FDA Recall #D-0422-2022 — Class II — December 6, 2021
Product Description
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03
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
40 droptainers
Distribution
nationwide
Code Information
11-2021-02@2 12/16/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated