# FDA recall D-0805-2021

> **ICU Medical Inc** · Class I · drug recall initiated 2021-09-03.

## 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.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0805-2021
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-03
- **Report date:** 2021-09-22
- **Termination date:** 2023-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0805-2021

## Citation

> AI Analytics. FDA recall D-0805-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0805-2021. Source: US FDA. Licensed CC0.

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