Travasol Injection
FDA Recall NDC 0338-0644
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Travasol (NDC 0338-0644). A significant event, classified as Class II, was initiated on Nov 12, 2013 by Baxter Healthcare Corporation. The reported reason for this action was: "Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2013 Class II Recall: Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Recall Number
Class II Terminated
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Nov 12, 2013
Dec 25, 2013
14,622 bags
Recall Profile & Regulatory Data
Event ID
66820
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 10, 2015
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.
Batch or Lot Expiration Information
Lot# Lot: P302646, Exp 5/31/15
Affected Packages Involved in this Recall
0338-0644-03Product
0338-0644-04Product
0338-0644-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
