ProSol — Class II drug recall D-1542-2014
Terminated recall by Baxter Healthcare Corp, reported 2014-08-27, distributed nationwide. Presence of Particulate Matter: identification of particulates in a retention sample that have been identified
| Recall number | D-1542-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp, Deerfield, IL, United States |
| Recall initiated | 2014-08-04 |
| Classified | 2014-08-18 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 6,204 bags |
| Reason classes | specification failure |
| NDC | 00338-0499, 00338-0499-06 |
| Lot numbers | 08/14, P306225 |
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 for recall
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).
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-1542-2014. 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.