Drug product
5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
D-1688-2012
Product summary
- Event
- Event 63189
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,064 containers
- Official record key
drug-enforcement:D-1688-2012
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 #: C828814, Exp 12/12; C841551, Exp 04/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination