Drug Enforcement D-764-2014

Presence of Particulate Matter; Glass particulates observed in vials

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Status

Terminated

Classification

Class I

Report Date

January 29, 2014

Termination Date

February 10, 2015

Product Information

Product description
Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA
Product quantity
179,870 vials
Reason for recall
Presence of Particulate Matter; Glass particulates observed in vials
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Cubist Pharmaceuticals, Inc.
Address
65 Hayden Avenue

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-764-2014
Event ID
66041
Recall initiation date
August 29, 2013
Center classification date
January 17, 2014
Code info
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
More code info
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