FDAClass IOctober 8, 2014

Cubicin recall: Particulate Matter

CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC…

Why was Cubicin recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC…
Recalling firm
Cubist Pharmaceuticals, Inc.
Quantity
4,966,575 Vials
Distribution
Nationwide Foreign: Israel, Taiwan
Recall date
October 8, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls