CLASS II Drug recall · Reported 25 Dec 2013 · FDA Enforcement Report
10%, Travasol (Amino Acid) Injection, Pharmacy recalled
Baxter Healthcare is recalling 10%, Travasol (Amino Acid) Injection, Pharmacy Not for Direct Infusion, Baxter Healthcare, distributed nationwide in the US. The recall was initiated on 12 Nov 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-368-2014
- FDA event ID
- 66820
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Travasol
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2013
- FDA classified
- 17 Dec 2013
- Reported
- 25 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Nov 2013 | Recall initiated by company | |
| 17 Dec 2013 | Classified by FDA | +35 days |
| 25 Dec 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Which lots are affected?
Lot: P302646, Exp 5/31/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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