Drug product
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07
D-831-2013
Product summary
- Event
- Event 65784
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39,486 containers
- Official record key
drug-enforcement:D-831-2013
Official wording
Reason: Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Code information: Product Code: L5B4826, Lot #: C886820, Exp 11/14
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.