FDA Recall D-0229-2015

Cubist Pharmaceuticals, Inc. · Lexington, MA

Class I — life-threatening Terminated 721 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01

Lot / code: Lot #'s: CDC203, Exp 12/2015; CDC207, Exp 01/2016; CDC213, Exp 02/2016; CDC217, Exp 03/2016; CDC226, Exp 04/2016; CDC234, CDC235, Exp 05/2016; CDC243, CDC246, Exp 07/2016.

Quantity: 371,879 Vials

Reason for recall

Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.

Recall record

Recall number: D-0229-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide and Puerto Rico.
Recall initiated: 2014-08-08
Classified by FDA Center: 2014-10-30
FDA published: 2014-11-05
Terminated: 2016-07-29
Recalling firm: Cubist Pharmaceuticals, Inc.
Firm location: Lexington, MA

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