Drug product
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
D-0321-2023
Product summary
- Event
- Event 91466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 bags
- Official record key
drug-enforcement:D-0321-2023
Official wording
Reason: Lack of sterility assurance
Code information: Beyond Use Date: December 25-31, 2022
Distribution pattern: Dispensed to Patients Nationwide.
Derived failure modes
-
Sterility assurance
Lack of sterility