Drug 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.
D-368-2014
Product summary
- Event
- Event 66820
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,622 bags
- Official record key
drug-enforcement:D-368-2014
Official wording
Reason: Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Code information: Lot: P302646, Exp 5/31/15
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility