Drug product
Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, 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.
D-458-2015
Product summary
- Event
- Event 70148
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4 bags
- Official record key
drug-enforcement:D-458-2015
Official wording
Reason: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information: lot numbers 37-74792 and 37-74635, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74792-0-2-R and CAPS Rx: 37-74635-0-2-R, Disp ID: 37-1124677 and Disp ID: 37-1124679
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
microbial contamination
-
Potency or specification failure
Out of specification