Drug product
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
D-1276-2014
Product summary
- Event
- Event 67608
- Status
- Terminated
- Classification
- Class I
- Quantity
- 27,169 containers
- Official record key
drug-enforcement:D-1276-2014
Official wording
Reason: Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Code information: Lot number: C903799, Exp 05/15
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter