Drug product
Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, 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-448-2015
Product summary
- Event
- Event 70148
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1 bag
- Official record key
drug-enforcement:D-448-2015
Official wording
Reason: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information: lot number 37-74547, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74547-0-1-R, Disp ID: 37-1124708
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
microbial contamination
-
Potency or specification failure
Out of specification