August 2014 FDA Recall Drug by Cubist Pharmaceuticals, Inc.
D-0229-2015 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Cubist Pharmaceuticals, Inc. on August 8, 2014 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0229-2015

Reason for Recall
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Initiated
08-08-2014
Reported
11-05-2014
Quantity
371,879 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67180
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cubist Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration 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.