FDA Drug recall D-1035-2014
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only
- FDA Drug
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only by Hospira, citing lack of Assurance of Sterility; potential leakage from administrative port.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1035-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-09 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
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
Lack of Assurance of Sterility; potential leakage from administrative port.
Identifiers
| code_info | Lot #: 26-123-JT, Exp: 8/14 |
|---|
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-1035-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.