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.
FDA recall notice · announced December 25, 2013 · Baxter Healthcare
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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
Notes
Distribution: Nationwide
Lot/code information: Lot: P302646, Exp 5/31/15
Quantity: 14,622 bags
Status: Terminated
Products in this recall event:
- 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. (D-368-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.