FDA recall D-764-2014

Cubist Pharmaceuticals, Inc. · Class I · drug

Product

Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA

Reason for recall

Presence of Particulate Matter; Glass particulates observed in vials

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-08-29
Report date: 2014-01-29
Termination date: 2015-02-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-764-2014