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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

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
Recall Number D-1688-2012
Classification Class II
Code Info Lot #: C828814, Exp 12/12; C841551, Exp 04/13
Product Distributed Qty 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).

Event Detail

Event Id 63189
Product Type Drugs
Status Ongoing
Recalling Firm Baxter Healthcare Corp.
City Round Lake
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico