Drug Enforcement D-1687-2012

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

Status

Terminated

Classification

Class II

Report Date

October 3, 2012

Termination Date

May 4, 2015

Product Information

Product description
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
Product quantity
2,976 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-1687-2012
Event ID
63189
Recall initiation date
September 21, 2012
Center classification date
September 25, 2012
Code info
Lot #: C832840, Exp 02/13
More code info
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