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D-368-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-368-2014 was initiated by Baxter Healthcare Corp. on Nov 12, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured The recall status is terminated (terminated Jun 10, 2015). Affected quantity: 14,622 bags.

Recall Details

Product Type: Drugs
Report Date: Dec 25, 2013
Initiation Date: Nov 12, 2013
Termination Date: Jun 10, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,622 bags

Product Description

10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06.

Reason for Recall

Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured

Distribution Pattern

Nationwide

Code Information

Lot: P302646, Exp 5/31/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-368-2014
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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