Home / Recalls / Cubist Pharmaceuticals, Inc. / D-0229-2015

D-0229-2015 Class I Terminated

Recalled by Cubist Pharmaceuticals, Inc. — Lexington, MA

Recall Details

Product Type
Drugs
Report Date
November 5, 2014
Initiation Date
August 8, 2014
Termination Date
July 29, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
371,879 Vials

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide and Puerto Rico.

Code Information

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.

Other recalls by Cubist Pharmaceuticals, Inc.

  • D-0001-2015 Class I — CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufacture (August 1, 2014)
  • D-1382-2014 Class I — CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufacture (April 17, 2014)
  • D-764-2014 Class I — Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use (August 29, 2013)