FDA recall D-0229-2015

Product

CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01

Reason for recall

Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2014-08-08

Report date

2014-11-05

Termination date

2016-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0229-2015