Aminosyn II — Class I drug recall D-461-2014
Terminated recall by Hospira Inc., reported 2014-01-22, distributed nationwide. Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair
| Recall number | D-461-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-08-30 |
| Classified | 2014-01-13 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2015-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 17,256 containers |
| Reason classes | specification failure |
| NDC | 00409-4164-03 |
| Lot numbers | 08/14, 26-138-JT |
Product
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
Reason for recall
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
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-461-2014. 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.