November 2013 FDA Recall Travasol by Baxter Healthcare Corp.
D-368-2014 - Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured

This Class II drug recall was voluntarily initiated by Baxter Healthcare Corp. on November 12, 2013 for the product Travasol. The FDA reported the reason for recall as lack of assurance of sterility; drug product leaking from container therefore sterility cannot be assured. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-368-2014

Reason for Recall
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Initiated
11-12-2013
Reported
12-25-2013
Quantity
14,622 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66820
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Baxter Healthcare Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-10-2015
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# Lot: P302646, Exp 5/31/15

Affected Packages Involved in this Recall

0338-0644-03 Travasol
0338-0644-04 Travasol
0338-0644-06 Travasol