Drug 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
D-437-2015
Product summary
- Event
- Event 70148
- Status
- Terminated
- Classification
- Class I
- Quantity
- 20 bags
- Official record key
drug-enforcement:D-437-2015
Official wording
Reason: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information: lot number 37-74529, EXP: 24 DEC 2014, Made on 15 DEC 2014, CAPS Rx: 37-74529-0-20-R, Disp ID: 37-1124540
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
microbial contamination
-
Potency or specification failure
Out of specification