August 2013 FDA Recall Drug by Cubist Pharmaceuticals, Inc.
D-764-2014 - Presence of Particulate Matter; Glass particulates observed in vials

This Class I drug recall was voluntarily initiated by Cubist Pharmaceuticals, Inc. on August 29, 2013 for the product Drug. The FDA reported the reason for recall as presence of particulate matter; glass particulates observed in vials. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-764-2014

Reason for Recall
Presence of Particulate Matter; Glass particulates observed in vials
Initiated
08-29-2013
Reported
01-29-2014
Quantity
179,870 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66041
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2015
Product Description About Product Description
Full technical description of the product.
Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA

Batch or Lot Expiration Information

Lot# 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