TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA...
FDA Recall #D-0321-2023 — Class II — December 27, 2022
Product Description
TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml, Rx only, use with Curlin 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
24 bags
Distribution
Dispensed to Patients Nationwide.
Code Information
Beyond Use Date: December 25-31, 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated