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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Lot #: a) C841114, C841254, Exp 09/12; C842229, C842898, C843037, C843326, C844209, Exp 10/12; C844456, C844928, C846089, C846246, C847178, Exp 11/12; C848044, C848804, C849869, C849810, C850313, Exp 12/12; C852574, C852673, C853168, C853275, C853473, Exp 01/13; C854331, C855098, C855551, Exp 02/13; C856690, C856815, C857813, Exp 03/13; C858829, C858951, C859884, C860049, C860304, C860304A, C860452, C861138, Exp 04/13; C861252, C861971, C862748, C862854, Exp 05/13; C865576, C865683, C866079, Exp 06/13; C866947, C867283, C867424, C867960, C868455, Exp 07/13; b) C818039, Exp 09/12; C821793, Exp 10/12; C824276, C825679, Exp 11/12; C828350, Exp 12/12; C830323, C832105, Exp 01/13; C834986, C836114, Exp 03/13; C840736, Exp 04/13; C843433, Exp 05/13; C844829, C845784, Exp 06/13; C848333, C850446, C850446A, Exp 07/13; C852376, C852939, Exp 08/13; C856443, C857417, C857656, C858381, Exp 10/13; C858498, C859470, C859652, Exp 11/13; C863365, Exp 12/13; C863738, C863852, C865451, C866392, Exp 01/14; C867846, Exp 02/14 Class II Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). 753,941 containers D-1686-2012
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 Lot #: C832840, Exp 02/13 Class II Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). 2,976 containers D-1687-2012
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 Lot #: C828814, Exp 12/12; C841551, Exp 04/13 Class II Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). 5,064 containers D-1688-2012
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 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 Class II Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). 897,496 containers D-1689-2012
Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Lot #: a) C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13; b) C855445, Exp 09/13; C861492, Exp 12/13 Class II Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). 55,664 containers D-1690-2012
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