Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling four lots of CUBICIN® (daptomycin for injection) to the user level due to the presence of particulate matter found in a number of vials from these lots.
|Product Description||Lot #|
|First Ship Date||Last Ship Date|
(daptomycin for injection)
No adverse events have been reported to date in association with a product complaint of vials containing glass particulates.
Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots, quarantine and discontinue distribution of all recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EST, Monday through Friday, to arrange for return and replacement of affected lots.
The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically non-serious.
As noted in the package insert for CUBICIN, parenteral drug products should be carefully inspected visually for particulate matter prior to administration. Healthcare providers should not use any CUBICIN vials containing particulate matter.
Patient safety is Cubist’s top priority and the Company wants to ensure that patients and the healthcare professionals using CUBICIN are aware of this recall and of what actions, if any, they should take. Cubist is arranging for return of recalled product. An internal investigation has preliminarily identified the root cause as a manufacturing issue with one of our suppliers. Cubist has suspended all manufacturing with the supplier until corrective and preventative measures have been taken.
For healthcare professionals and pharmacists with questions regarding this recall may contact Cubist Medical Information at (877) 282-4786 between the hours of 8 a.m. to 5:30 p.m. EST, Monday through Friday.
Adverse events or quality problems experienced with the use of this product may also be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Cubist Medical Information
Julie DiCarlo, 781-860-8063
Senior Director, Corporate Communications
|Alexion Provides Update on Previously Communicated November 2013 Voluntary Nationwide Recall of Two Lots of Soliris® (eculizumab) Concentrated Solution for Intravenous Infusion (2013/12/13)|
|Cubist Pharmaceuticals Issues $800 Million of Convertible Senior Notes (2013/9/10)|
|Important Safety Notice: Loblaw Issues Voluntary Recall of Life at Home LED 70 count Outdoor Christmas lights (2013/12/14)|
|Perrigo Initiates Nationwide Voluntary Product Recall Of Acetaminophen Infant Suspension Liquid, 160 mg/5 mL, Due To A Potential Defect With The Co-Packaged Oral Syringe (2013/11/1)|
|Ampio Pharmaceuticals Reports Positive Results in the Extended Spring study of Osteoarthritis of the Knee Following a Single Intra-articular Injection of Ampion™ (2013/11/4)|
|Harley-Davidson Issues Voluntary Recalls Of Certain 2014 Motorcycles (2013/10/16)|
|Perrigo Issues Voluntary Recall for Infant Medicine (2013/11/1)|
|Start Premium Trial||Register For Free|
|P||F||Fund Financial Data (13,000+ funds)|
|P||F||Stock Financial Data (7,000+ stocks)|
|P||F||Stock and Fund Screeners (basic)|
|P||F||Investing Articles and Market Commentary|
|P||F||Articles Archive (>30 days)|
|P||F||Discuss (dozens of stock, fund, bond, and general bulletin boards)|
|P||F||Portfolio Manager (basic)|
|P||F||Morningstar Investment Classroom|
|P||F||Access Your Portfolio Anytime, Anywhere via Your Mobile Device|
|P||Morningstar Fund Analyst Reports (full research on 1,700 funds, ETFs, and CEFs)|
|P||Morningstar Stock Analyst Reports (full research on more than 1,100 stocks)|
|P||Portfolio Manager (advanced with 10 X-Ray analyses, including recommendations)|
|P||Portfolio Monitor (monthly and on-demand personalized portfolio statements)|
|P||Morningstar Proprietary Stock Information (stock star ratings, buy/sell prices, economic moat ratings, and more)|
|P||Morningstar 5-Star Stock and Fund Favorites & Red Flags eNewsletters|
|P||Premium Stock and Fund Screeners (advanced with nearly infinite ways to find the best securities for you)|
|P||Discounts on Morningstar newsletters, books, seminars, and more|
Access these features and more when you sign up for Free Membership.
Join Morningstar today. It's Free.
Access these features and more when you sign up for Premium Membership.
Start your free 14-day trial today online
Your subscription may be tax deductible. Please contact your tax advisor.