FDA Drug recall D-1689-2012

0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02

FDA Drug
Class II
terminated
Published 2012-10-03

On 2012-10-03 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02 by Baxter Healthcare, citing chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1689-2012
Classification	Class II
Status	terminated
Initiated	2012-09-21
Published	2012-10-03
Last updated	2026-09-13 11:51 UTC
Company	Baxter Healthcare
Distribution	US

Product

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

Reason

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

Identifiers

code_info	Lot #: a) C840892, C841007, C841403, Exp 09/12; C842377, C842757, C843748, C843946, Exp 10/12; C844332, C845065, C84519… 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, C8

code_info

Lot #: a) C840892, C841007, C841403, Exp 09/12; C842377, C842757, C843748, C843946, Exp 10/12; C844332, C845065, C84519…

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, C8

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1689-2012%22

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