Cubist Pharmaceuticals Issues Voluntary U.S. Recall of Certain Lots of CUBICIN (daptomycin for injection) 500 mg in 10 mL sin...
August 06 2014 - 8:00AM
Business Wire
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it
is voluntarily recalling certain lots of CUBICIN® (daptomycin for
injection) to the user level due to the potential presence of glass
particulate matter in vials produced by a contract manufacturer.
Please click here for the list of
affected CUBICIN lot information.
The administration of a glass particulate, if present in an
intravenous drug, poses a potential safety risk to patients such as
a thromboembolism or a life-threatening pulmonary emboli. Other
events such as phlebitis, mechanical block of the capillaries or
arterioles, activation of platelets, or subsequent generation of
microthrombi are also possible. Patients with a 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.
Cubist has decided to issue a voluntary recall of these lots as
a result of an issue with a manufacturing line of one of our
suppliers that could result in glass particulate matter in vials.
No complaints of glass in vial or adverse events in
association with a product complaint of glass in vial have been
reported to date for these recalled lots.
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 www.cubicin.com). CUBICIN was
distributed nationwide to multiple consignees.
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 this recalled lots 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 lots.
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.
To report an adverse event or a product complaint, please call
(877) 282-4786. Adverse events or quality problems experienced with
the use of this product may also be reported to the FDA’s MedWatch
Adverse Events Program either online, by regular mail or by
fax.
- Complete and submit the report
Online: http://www.fda.gov/MedWatch/report.htm
- Regular mail or Fax: Download
form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088
to request a reporting form, then complete and return to the
address on the pre-addressed form, or submit by fax to
1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S.
Food and Drug Administration.
Cubist Pharmaceuticals, Inc.CONSUMERS:Cubist Medical
Information, 877-282-4786orMEDIA:Julie DiCarlo, 781-860-8063Senior
Director, Corporate Communicationsjulie.dicarlo@cubist.com