CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home...
FDA Recall #D-0280-2023 — Class II — December 27, 2022
Product Description
CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason for Recall
Lack of sterility assurance
Recalling Firm
Sentara Infusion Services — Chesapeake, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
71 bags total
Distribution
Dispensed to Patients Nationwide.
Code Information
Beyond Use Date December 24-31, 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated