# FDA recall D-461-2014

> **Hospira Inc.** · Class I · drug recall initiated 2013-08-30.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-461-2014
- **Recalling firm:** Hospira Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-30
- **Report date:** 2014-01-22
- **Termination date:** 2015-08-21

- **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-461-2014

## Citation

> AI Analytics. FDA recall D-461-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-461-2014. Source: US FDA. Licensed CC0.

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