Sentara Infusion Services recalls TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700…

Recall date

December 27, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0320-2023

FDA classification

Class II

Brand / firm

Sentara Infusion Services

Sold / distributed

Dispensed to Patients Nationwide.

Why it was recalled

Lack of sterility assurance

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105GM LIP: 45GM 2700ML, (e) TPN: AA100GM ; DEX185GM ; LIP50GM IN 1500ML, (f) TPN: AA 150GM ; DEX 220GM ; LIP 45GM IN 2400 ml, (g) TPN: AA 60GM ; DEX 200GM ; LIP 30GM IN 1500 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320