ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Ind...
FDA Recall #D-0312-2023 — Class II — December 27, 2022
Product Description
ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, 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
15 bags
Distribution
Dispensed to Patients Nationwide.
Code Information
Beyond Use Date: December 29-30, 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated