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.

Lot / code: Lot #: 081753F, 081803F, 081853F, Exp 08/2014; 090103F, 090153F, 090303F, 090353F, 090403F, 090453F, 090503F, Exp 09/2014; 100503F, 100553F, 100603F, 100653F, 100703F, 100753F, 100803F, 100853F, 100903F, Exp 10/2014; 101303F, 110303F, 110353F, 110403F, 110453F, 110503F, 110603F, 110653F, 110703F, Exp 11/2014; 120303F, 120353F, 120403F, 120453F, 120503F, 120553F, 120653F, 120703F, Exp 12/2014; 140453F, Exp 02/2015; 140603F, 140653F, 140703F, 150203F, 150253F, 150303F, 150353F, 150403F, 150453F, Exp 03/2015; 160853F, 160903F, 160953F, 161003F, 161053F, 161103F, Exp 05/2015; 181003F, 181053F, 181103F, 181153F, 181603F, 181653F, 181703F, Exp 06/2015; 201503F, 201553F, 201603F, Exp 08/2015; 201753F, 210453F, Exp 09/2015; 210503F, 210553F, 210603F, 210653F, 220353F, 220403F, 220453F, Exp 10/2015; 220503F, 220553F, 220603F, 230303F, 230353F, 230403F, 230453F, 230503F, 230553F, Exp 11/2015; 240053F, 240153F, 240203F, 240253F, 240303F, Exp 12/2015; 260603F, 260653F, 260703F, Exp 02/2016; 271303F, 271353F, 271403F, 271453F, 271503F, 271553F, Exp 03/2016; 280203F, 280253F, 280303F, 280403F, Exp 04/2016; 290203F, 290303F, 290353F, Exp 06/2016.

Quantity: 4,966,575 Vials

Reason for recall

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

Recall record

Recall number

D-0001-2015

Classification

Class I

Status

Terminated

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Press Release

Distribution

Nationwide Foreign: Israel, Taiwan

Recall initiated

2014-08-01

Classified by FDA Center

2014-10-01

FDA published

2014-10-08

Terminated

2016-06-29

Recalling firm

Cubist Pharmaceuticals, Inc.

Firm location

Lexington, MA