August 2014 FDA Recall Drug by Cubist Pharmaceuticals, Inc.
D-0001-2015 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Cubist Pharmaceuticals, Inc. on August 1, 2014 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0001-2015

Reason for Recall
Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
Initiated
08-01-2014
Reported
10-08-2014
Quantity
4,966,575 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68969
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cubist Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide Foreign: Israel, Taiwan
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-29-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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.