FDA Drug recall D-1542-2014
ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutritio…
- FDA Drug
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutritio… by Baxter Healthcare, citing presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (conta….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1542-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-04 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.
Reason
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Identifiers
| ndc | 0338-0499-06 |
|---|---|
| code_info | Lot #: P306225, Exp 08/14 |
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-1542-2014%22
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