FDA Recall D-764-2014

Cubist Pharmaceuticals, Inc. · Lexington, MA

Class I — life-threatening Terminated 530 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 lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA

Lot / code: Lot Numbers: Lot 950453F, Exp. 12/06/2013 Lot 090203F, Exp. 09/07/2014 Lot 201703F, Exp. 08/31/2015 Lot 201653F, Exp. 09/01/2015

Quantity: 179,870 vials

Reason for recall

Presence of Particulate Matter; Glass particulates observed in vials

Recall record

Recall number: D-764-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2013-08-29
Classified by FDA Center: 2014-01-17
FDA published: 2014-01-29
Terminated: 2015-02-10
Recalling firm: Cubist Pharmaceuticals, Inc.
Firm location: Lexington, MA

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