Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx on...
FDA Recall #D-0063-2024 — Class II — October 2, 2023
Product Description
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, 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
662 dropper
Distribution
Nationwide within the United States
Code Information
Lot #: 67659, Exp. Date 10/16/2023; 70316, Exp. Date 1/30/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated