Product: Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, 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