PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: February 22, 2023 Initiated: December 27, 2022 #D-0321-2023

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

Details

Recalling Firm
Sentara Infusion Services
Units Affected
24 bags
Distribution
Dispensed to Patients Nationwide.
Location
Chesapeake, VA

Frequently Asked Questions

What product was recalled?
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. Recalled by Sentara Infusion Services. Units affected: 24 bags.
Why was this product recalled?
Lack of sterility assurance
Which agency issued this recall?
This recall was issued by the FDA Drug on February 22, 2023. Severity: Moderate. Recall number: D-0321-2023.