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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 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Recall Number D-1689-2012
Classification Class II
Code Info Lot #: a) C840892, C841007, C841403, Exp 09/12; C842377, C842757, C843748, C843946, Exp 10/12; C844332, C845065, C845198, C845347, C846873, C847301, C847608, Exp 11/12; C848481, C848937, C849554, C850180, Exp 12/12; C850966, C851097, C851212, C852459, C853044, C853614, Exp 01/13; C853747, C854455, C854711, C854836, C854943, C856013, C856138, Exp 02/13; C856948, C858027, Exp 03/13; C858712, C859066, C859199, C859389, C860569, C861021, Exp 04/13; C861856, C862953, C863076, C863183, Exp 05/13; C865188, C865824, C866178, C866178A, Exp 06/13; C867168, C868117, C868570, C868703, Exp 07/13; b) C818187, C819367, Exp 09/12; C821686, Exp 10/12; C823377, Exp 11/12; C826255, C828111, C828228, Exp 12/12; C830455, C830604, Exp 01/13; C832964, C833152, Exp 02/13; C839134, C840587, Exp 04/13; C842740, C843649, Exp 05/13; C844647, C845941, C847038, Exp 06/13; C848184, C849117, C850545, Exp 07/13; C850842, C851568, C852806, Exp 08/13; C853853, C854216, C854216A, C855213, Exp 09/13; C856567, C858142, C858258, Exp 10/13; C858613, C859777, C859777A, C860916, Exp 11/13; C861617, C861724, Exp 12/13; C865311, C866285, Exp 01/14; C866632, C866830, Exp 02/14
Product Distributed Qty 897,496 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
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