PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: December 25, 2013 Initiated: November 12, 2013 #D-368-2014

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

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
14,622 bags
Distribution
Nationwide
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Baxter Healthcare Corp.. Units affected: 14,622 bags.
Why was this product recalled?
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Which agency issued this recall?
This recall was issued by the FDA Drug on December 25, 2013. Severity: Moderate. Recall number: D-368-2014.