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Recall Observatory FDA recall evidence

Drug 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

D-0229-2015

August 08, 2014

Class I

Product summary

Firm
Cubist Pharmaceuticals, Inc.
Event
Event 67180
Status
Terminated
Classification
Class I
Quantity
371,879 Vials
Official record key
drug-enforcement:D-0229-2015

Official wording

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

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.

Distribution pattern: Nationwide and Puerto Rico.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter