Exact FDA event identifier

Event 63189

5 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 21, 2012
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Baxter Healthcare Corp.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 5

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

D-1686-2012

Recall number: D-1686-2012
Initiated: September 21, 2012
Classification: Class II
Status: Terminated
Recalling firm: Baxter Healthcare Corp.
Quantity: 753,941 containers

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 5

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

D-1687-2012

Recall number: D-1687-2012
Initiated: September 21, 2012
Classification: Class II
Status: Terminated
Recalling firm: Baxter Healthcare Corp.
Quantity: 2,976 containers

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: C832840, Exp 02/13

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 5

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

D-1688-2012

Recall number: D-1688-2012
Initiated: September 21, 2012
Classification: Class II
Status: Terminated
Recalling firm: Baxter Healthcare Corp.
Quantity: 5,064 containers

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: C828814, Exp 12/12; C841551, Exp 04/13

Distribution pattern

Nationwide and Puerto Rico

drug · product 4 of 5

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

D-1689-2012

Recall number: D-1689-2012
Initiated: September 21, 2012
Classification: Class II
Status: Terminated
Recalling firm: Baxter Healthcare Corp.
Quantity: 897,496 containers

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Nationwide and Puerto Rico

drug · product 5 of 5

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

D-1690-2012

Recall number: D-1690-2012
Initiated: September 21, 2012
Classification: Class II
Status: Terminated
Recalling firm: Baxter Healthcare Corp.
Quantity: 55,664 containers

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Chemical Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: a) C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13; b) C855445, Exp 09/13; C861492, Exp 12/13

Distribution pattern

Nationwide and Puerto Rico