Drug product
10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
D-1687-2012
Product summary
- Event
- Event 63189
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,976 containers
- Official record key
drug-enforcement:D-1687-2012
Official wording
Reason: Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Code information: Lot #: C832840, Exp 02/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination