AMINOSYN II 15% An Amino Acid Injection — Class I drug recall D-0805-2021
Terminated recall by ICU Medical Inc, reported 2021-09-22, distributed nationwide. Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material alon
| Recall number | D-0805-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, Lake Forest, IL, United States |
| Recall initiated | 2021-09-03 |
| Classified | 2021-09-17 |
| Reported by FDA | 2021-09-22 |
| Terminated | 2023-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,112 flexible |
| Reason classes | specification failure |
| NDC | 00409-7171-17 |
| Lot numbers | 4989094 |
| Expiration dates | 2022-04-01 |
Product
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
Reason for recall
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
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-0805-2021. 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.