Product: Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, 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