FDA recall D-143-2013

Product

Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.

Reason for recall

Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.

Distribution

CA & VA

Key facts

Status

Terminated

Initiation date

2013-01-16

Report date

2013-02-13

Termination date

2013-07-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

South San Francisco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-143-2013