Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Ph...
FDA Recall #D-0053-2024 — Class II — October 2, 2023
Product Description
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, 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
128 bags
Distribution
Nationwide within the United States
Code Information
Lot #: 69802, Exp. Date 02/28/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated