# FDA recall D-1049-2014

> **Alexion Pharmaceuticals, Inc.** · Class I · drug recall initiated 2013-11-04.

## Product

Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT  06410, NDC 25682-001-01, UPC 3 25682-001-01 6.

## Reason for recall

Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.

## Distribution

Nationwide, Puerto Rico, Jamaica, and Grenada.

## Key facts

- **Recall number:** D-1049-2014
- **Recalling firm:** Alexion Pharmaceuticals, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-11-04
- **Report date:** 2014-02-05
- **Termination date:** 2015-03-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cheshire, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1049-2014

## Citation

> AI Analytics. FDA recall D-1049-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1049-2014. Source: US FDA. Licensed CC0.

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