Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25...
FDA Recall #D-0421-2022 — Class II — December 6, 2021
Product Description
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
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
2562 syringes
Distribution
nationwide
Code Information
09-2021-15@2 12/28/2021 & 11-2021-02@3 02/14/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated