Drug product
Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 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.
D-462-2015
Product summary
- Event
- Event 70148
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1 bag
- Official record key
drug-enforcement:D-462-2015
Official wording
Reason: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information: lot number 37-74653, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74653-0-1-R, Disp ID: 37-1124735
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
microbial contamination
-
Potency or specification failure
Out of specification