# FDA recall D-1035-2014

> **Hospira Inc.** · Class II · drug recall initiated 2014-01-09.

## Product

Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only.  Hospira Inc, Lake Forest, IL, 60045.  NDC: 0409-4196-05

## Reason for recall

Lack of Assurance of Sterility; potential leakage from administrative port.

## Distribution

Nationwide including Puerto Rico

## Key facts

- **Recall number:** D-1035-2014
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-09
- **Report date:** 2014-02-05
- **Termination date:** 2015-05-19

- **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-1035-2014

## Citation

> AI Analytics. FDA recall D-1035-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1035-2014. Source: US FDA. Licensed CC0.

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