Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Nine Lots of CUBICIN (daptomycin for injection) 500 mg in 10 mL ...
August 08 2014 - 05:47PM
Business Wire
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it
is voluntarily recalling nine lots of CUBICIN® (daptomycin for
injection) to the user level following complaints of foreign
particulate matter in reconstituted vials.
The administration of particulate matter, if present in an
intravenous drug, poses a potential safety risk to patients such as
a thromboembolism or a life-threatening pulmonary embolism. 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 particulate can also lead to formation of
granulomas, which represent a protective local inflammatory
response to the foreign material. To date, no reports of adverse
events have been associated with product complaints of particulate
matter from these 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.
Product Description
Lot #
ExpirationDate
Ship Dates(MM/DD/YY)
CUBICIN®
(daptomycin for injection) 500
mg
NDC 67919-011-01;
UPC 3 67919-011-01 6
CDC203 DEC 2015 9/2/13
through 9/24/13 CDC207 JAN 2016 9/16/13
through 10/15/13 CDC213 FEB 2016
10/1/13 through 10/7/13 CDC217 MAR 2016
12/2/13 through 12/11/13 CDC226 APR 2016
7/29/13 through 8/26/13 CDC234 MAY 2016
8/26/13 through 9/19/13 CDC235 MAY 2016
9/19/13 through 10/17/13 CDC243 JUL 2016
10/17/13 through 11/12/13 CDC246
JUL 2016 11/12/13 through 12/2/13
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 these 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.
Cubist is arranging for return of recalled product. 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 Information877-282-4786orMEDIA:Cubist
Pharmaceuticals, Inc.Julie DiCarlo, 781-860-8063Senior Director,
Corporate Communicationsjulie.dicarlo@cubist.com