Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers,...
FDA Recall #D-0055-2024 — Class II — October 2, 2023
Product Description
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Pine Pharmaceuticals, LLC — Tonawanda, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2181 droppers
Distribution
Nationwide within the United States
Code Information
Lot #: 67008, Exp. Date 10/04/2023; 67685, Exp. Date 10/21/2023; 67853, Exp. Date 10/25/2023; 69967, Exp. Date 01/13/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated