Product: University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box. each container is lined with a polystyrene insert; CAPS, Allentown, PA
Reason for recall: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recall initiated: 20141217
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated