Drug product
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
D-1610-2014
Product summary
- Event
- Event 69011
- Status
- Terminated
- Classification
- Class I
- Quantity
- 50,530 bags
- Official record key
drug-enforcement:D-1610-2014
Official wording
Reason: Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Code information: Lot #: C940700, C940841, Exp 05/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter