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D-1688-2012 Class II Terminated

Recalled by Baxter Healthcare Corp. — Round Lake, IL

FDA drug recall D-1688-2012 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: 5,064 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: 5,064 containers

Product Description

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

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1688-2012
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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