Aminosyn 3 — Class II drug recall D-1035-2014
Terminated recall by Hospira Inc., reported 2014-02-05, distributed nationwide. Lack of Assurance of Sterility; potential leakage from administrative port.
| Recall number | D-1035-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-01-09 |
| Classified | 2014-01-24 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2015-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 15,258 bags |
| Reason classes | sterility, packaging |
| NDC | 00409-4196-05 |
| Lot numbers | 26-123-JT, 8/14 |
Product
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
Reason for recall
Lack of Assurance of Sterility; potential leakage from administrative port.
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-1035-2014. 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.