FDA Drug recall D-0805-2021
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045
- FDA Drug
- Class I
- terminated
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class I recall of AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045 by Icu Medical, citing presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0805-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-09-03 |
| Published | 2021-09-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Icu Medical |
| Distribution | US |
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
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Identifiers
| code_info | Lot: 4989094 Exp. 01-APR-2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0805-2021%22
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