Telecom Signaling Industry News

TMCNet:  Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of One Lot of CUBICIN (daptomycin for injection) 500 mg in 10 mL single use vials Due to Presence of Particulate Matter

[April 18, 2014]

Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of One Lot of CUBICIN (daptomycin for injection) 500 mg in 10 mL single use vials Due to Presence of Particulate Matter

LEXINGTON, Mass. --(Business Wire)--

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer.

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.

No adverse events have been reported to date in association with a product complaint of vials containing glass particulate.

Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin is supplied in a single-use vial packaged in a carton (refer to The affected Cubicin lot information is contained in the table below. Cubicin was distributed Nationwide to multiple consignees.

Product Description Lot # Expiration Date Ship Dates (MM/DD/YYYY)

CUBICIN® (daptomycin for injection)

500 mg


NDC 67919-011-01; UPC 3 67919-011-01 6

280453F APR 2016 3/17/2014 through 3/25/2014

Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product lot listed should determine whether they have product from the recalled lot, quarantine and discontinue distribution of this recalled lot of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lot.

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 identified the root cause as a manufacturing issue with a single manufacturing line of one of our suppliers, and Cubist has suspended all manufacturing on this line.

For healthcare professionals and pharmacists with medical 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. EDT, Monday through Friday.

Adverse events or quality problems experienced with the use of this product may be reported to the FDA's 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.

[ Back To Telecom Signaling's Homepage ]

Featured Events

5G NA Signaling Day

November 14-16, 2016
Sheraton Dallas, Dallas, TX

Featured Webcasts

Securing The Signaling Interconnect: Oracle's Perspective On Recent Security Events

Today's telecommunications landscape is changing rapidly, and the "institution" of trust between networks that has been assumed over the decades is no longer relevant. We are now hearing of vulnerabilities in CSP interconnection points that have been known ...

Applications of Wi-Fi Calling

With all of the discussion about faster data access and richer content, it could be assumed that voice services no longer play an important role in the business model of the communications service provider. Join ReThink Technologies Research and Oracle Communications as we explore ...

Featured Whitepapers

Oracle Communications Diameter Signaling Router Main Differentiators

Diameter is the protocol used by network elements in LTE and 3G networks to enable and monetize services, such as voice, video and data. Diameter enables revenue-generating data services; including tiered data plans, loyalty programs, application specific QoS, content provider and Internet of Things (IoT) solutions ...

Multi-Layer Security Protection for Signaling Networks

The sanctity of mobile operators' networks and brands will depend greatly on their ability to deliver QoS guarantees to roaming and interconnect partners, while simultaneously protecting increasingly multimedia-savvy and socially connected ...

Featured Datasheets

Oracle Communications Diameter Signaling Router

Centralizing Diameter routing with cloud deployable Oracle Communications Diameter Signaling Router creates a secure signaling architecture that reduces the cost and complexity of the core network and enables elastic growth, interoperability and rapid introduction ...

Oracle Communications Mobile Security Gateway

The Oracle Communications Mobile Security Gateway is a high performance gateway that allows the Communications Service Provider (CSP) to cost effectively expand network coverage and increase capacity by incorporating Heterogeneous ...

Oracle Communications Evolved Communications Application Server

As service providers drive their networks toward an all-IP and virtualized state, they require the means to design and deliver compelling high definition voice, video and multimedia offers via Voice over LTE (VoLTE) and Voice over WiFi (VoWiFi) ...

Featured Infographic