Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of One Lot of CUBICIN (daptomycin for injection) 500 mg in 10 mL si...
April 18 2014 - 11:59AM
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 www.cubicin.com). 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.
- 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.
CONSUMERS:Cubist Medical Information, 877-282-4786orMEDIA:Julie
DiCarlo, 781-860-8063Senior Director, Corporate
Communicationsjulie.dicarlo@cubist.com