TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL dr...
FDA Recall #D-0060-2024 — Class II — October 2, 2023
Product Description
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL 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
1693 droppers
Distribution
Nationwide within the United States
Code Information
Lot #: 68184, Exp. Date 10/9/2023; 68623, Exp. Date 11/2/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated