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D-1690-2012 Class II Terminated

Recalled by Baxter Healthcare Corp. — Round Lake, IL

FDA drug recall D-1690-2012 was initiated by Baxter Healthcare Corp. on Sep 21, 2012 and is designated Class II. Reason for recall: Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). The recall status is terminated (terminated May 4, 2015). Affected quantity: 55,664 containers.

Recall Details

Product Type: Drugs
Report Date: Oct 3, 2012
Initiation Date: Sep 21, 2012
Termination Date: May 4, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 55,664 containers

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide and Puerto Rico

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1690-2012
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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