FDA recall D-1049-2014

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

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

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