# FDA recall D-0625-2017

> **Shire** · Class II · drug recall initiated 2017-03-17.

## Product

Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton,  Rx Only,  Dynax Corp., Burlington, MA. NDC47783-101-01

## Reason for recall

Presence of Particulate Matter: Glass

## Distribution

Nationwide and Kuwait

## Key facts

- **Recall number:** D-0625-2017
- **Recalling firm:** Shire
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-03-17
- **Report date:** 2017-04-12
- **Termination date:** 2021-05-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0625-2017

## Citation

> AI Analytics. FDA recall D-0625-2017. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0625-2017. Source: US FDA. Licensed CC0.

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