Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple ...
FDA Recall #D-0420-2022 — Class II — December 6, 2021
Product Description
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01
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
363 droptainers
Distribution
nationwide
Code Information
09-2021-15@1 12/28/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated