FDA recall D-0001-2015

Product

CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.

Reason for recall

Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.

Distribution

Nationwide Foreign: Israel, Taiwan

Key facts

Status

Terminated

Initiation date

2014-08-01

Report date

2014-10-08

Termination date

2016-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2015