Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by P...
FDA Recall #D-0054-2024 — Class II — October 2, 2023
Product Description
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, 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
881 pre-filled syringes
Distribution
Nationwide within the United States
Code Information
Lot #: 70363, Exp. Date 03/20/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated