FDA recall D-1382-2014

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: Customer complaint stating that one vial contained a glass shard.

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2014-04-17

Report date

2014-06-18

Termination date

2016-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1382-2014