10% — Class II drug recall D-368-2014
Terminated recall by Baxter Healthcare Corp., reported 2013-12-25, distributed nationwide. Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
| Recall number | D-368-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2013-11-12 |
| Classified | 2013-12-17 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2015-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 14,622 bags |
| Reason classes | sterility, packaging |
| NDC | 00338-0644, 00338-0644-03, 00338-0644-04, 00338-0644-06 |
| Lot numbers | P302646 |
| Expiration dates | 2015-05-31 |
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 for recall
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-368-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.