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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

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.
Recall Number D-368-2014
Classification Class II
Code Info Lot: P302646, Exp 5/31/15
Product Distributed Qty 14,622 bags
Reason For Recall Lack of Assurance of Sterility; Drug product leaking from container, therefore sterility cannot be assured

Event Detail

Event Id 66820
Product Type Drugs
Status Ongoing
Recalling Firm Baxter Healthcare Corp.
City Deerfield
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide