LEUCINE Recall D-368-2014
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.
LEUCINE Recall D-368-2014 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-368-2014 |
| Event ID | 66820 |
| Brand | TRAVASOL |
| Generic Name | LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE |
| Manufacturer | LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE |
| Original Package? | 1 |
| Active Substance | LEUCINE PHENYLALANINE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide |
| Quantity | 14,622 bags |
| Recall Reason | Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured |
| Drug Classification | Class II |
| Drug Code Info | 20131225 |
| Product NDC | 0338-0644 |
| Product NUI | N0000175780 M0000922 |
| Pharma Class (EPC) | Amino Acid [EPC] |
| Pharma Class (CS) | Amino Acids [CS] |
| Recall Initiation Date | 20131112 |
| Report Date | 20131225 |
| Termination Date | 20150610 |
| Classification Date | 20131217 |
| Address | 1 Baxter Pkwy Deerfield, IL 60015-4625 United States |
| Recalling Firm | Baxter Healthcare Corp. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | GMW67QNF9C 47E5O17Y3R |
| Drug Application Number | NDA018931 |
| Structured Product Labeling (SPL ID) | 7c347ee1-821e-417e-b916-87be7145ab1f |
| Structured Product Labeling (SPL Set ID) | 8543b5be-0f43-4891-9e56-d7c39fe839b5 |
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