RecallRadar

FDA Drug recall D-368-2014

10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrit…

On 2013-12-25 the FDA classified a Class II recall of 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrit… by Baxter Healthcare, citing lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-368-2014
ClassificationClass II
Statusterminated
Initiated2013-11-12
Published2013-12-25
Last updated2026-09-13 11:51 UTC
CompanyBaxter Healthcare
DistributionUS

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

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

Identifiers

ndc0338-0644-03
ndc0338-0644-04
ndc0338-0644-06
code_infoLot: P302646, Exp 5/31/15

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-368-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.