FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Baxter Healthcare 10% Recall

10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Inf…

Baxter Healthcare Corp. · Deerfield, IL

Risk level
Class II
Reported by FDA
Dec 25, 2013
Recall ID
D-368-2014
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled 10% starting Nov 12, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-368-2014 on Dec 25, 2013. Reason: Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured

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.

Lot numbers, UPCs & expiration codes

Lot: P302646, Exp 5/31/15

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-368-2014
Classification
Class II
Status
Terminated
Recall initiated
Nov 12, 2013
FDA report date
Dec 25, 2013
Quantity
14,622 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-368-2014, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
66820
Address
1 Baxter Pkwy
Code information
Lot: P302646, Exp 5/31/15
Postal code
60015-4625
Report date
Dec 25, 2013
Product type
Drugs
Recall number
D-368-2014
Classification
Class II
Recalling firm
Baxter Healthcare Corp.
Product quantity
14,622 bags
Termination date
Jun 10, 2015
Reason for recall
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide
Recall initiation date
Nov 12, 2013
Initial firm notification
Letter
Center classification date
Dec 17, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-368-2014, published Dec 25, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls