Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharma...
FDA Recall #D-0062-2024 — Class II — October 2, 2023
Product Description
Lidocaine HCl 4% ophthalmic solution, 3 mL single-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
1598 droppers
Distribution
Nationwide within the United States
Code Information
Lot #: 67443, Exp. Date 10/8/2023; 68775, Exp. Date 12/9/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated