Drug product
Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 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-439-2015
Product summary
- Event
- Event 70148
- Status
- Terminated
- Classification
- Class I
- Quantity
- 8 bags
- Official record key
drug-enforcement:D-439-2015
Official wording
Reason: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information: lot number 37-74756, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74756-0-8-R, Disp ID: 37-1124668.
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
microbial contamination
-
Potency or specification failure
Out of specification