FDA recall D-1512-2014

Product

Soliris (eculizumab), 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: Product failed the appearance for the presence of visible particles under labeled storage condition.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-06-02

Report date

2014-08-13

Termination date

2015-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cheshire, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1512-2014