10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Bax...
FDA Recall #D-368-2014 — Class II — November 12, 2013
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
Recalling Firm
Baxter Healthcare Corp. — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
14,622 bags
Distribution
Nationwide
Code Information
Lot: P302646, Exp 5/31/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated