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
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.
CUBICIN® (daptomycin for injection)
NDC 67919-011-01; UPC 3 67919-011-01 6
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
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
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