Recalls / Class II
Class IID-368-2014
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.
- Brand name
- Travasol
- Generic name
- Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine
- Active ingredients
- Alanine, Arginine, Glycine, Histidine, Isoleucine, Leucine, Lysine Hydrochloride, Methionine, Phenylalanine, Proline, Serine, Threonine, Tryptophan, Tyrosine, Valine
- Route
- Intravenous
- NDC
- 0338-0644
- FDA application
- NDA018931
- Affected lot / code info
- Lot: P302646, Exp 5/31/15
Why it was recalled
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 14,622 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-12
- FDA classified
- 2013-12-17
- Posted by FDA
- 2013-12-25
- Terminated
- 2015-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-368-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.