Status
Terminated
Drug Enforcement D-1688-2012
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Classification
Class II
Report Date
October 3, 2012
Termination Date
May 4, 2015
Product Information
- Product description
- 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
- Product quantity
- 5,064 containers
- Reason for recall
- Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Baxter Healthcare Corp.
- Address
-
Route 120 And Wilson Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1688-2012
- Event ID
- 63189
- Recall initiation date
- September 21, 2012
- Center classification date
- September 25, 2012
- Code info
- Lot #: C828814, Exp 12/12; C841551, Exp 04/13
- More code info
- —