Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 ...
FDA Recall #D-0057-2024 — Class II — October 2, 2023
Product Description
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, 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
4972 syringes
Distribution
Nationwide within the United States
Code Information
Lot #: 67918, Exp. Date 10/29/2023; 68033, Exp. Date 11/4/2023; 68515, Exp. Date 11/26/2023; 68528, Exp. Date 11/27/2023; 68618, Exp. Date 12/2/2023; 68651, Exp. Date 12/3/2023; 68767, Exp. Date 12/9/2023; 68829, Exp. Date 12/11/2023; 69820, Exp. Date 1/9/2024; 70733, Exp. Date 2/19/2024; 71068, Exp. Date 3/9/2024; 67345, Exp. Date 10/3/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated