Merck Recalls TEMODAR® and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child–Resistant Closure Requirement
August 18 2015 - 12:17PM
Business Wire
Patients Should Visually Examine Bottle Caps
for Cracks and if Cracks are Found, Ensure the Bottles are Stored
Out of the Reach of Children
Replacement Caps for Patients Are
Available
Medication Within the Bottles Is Not
Affected; Patients May Continue to Take Their Medicine as
Prescribed
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, in conjunction with the U.S. Consumer Product Safety
Commission (CPSC) today asked that all customers, including
patients, inspect all bottles of TEMODAR® (temozolomide) capsules
and all bottles of Temozolomide capsules (generic) for potential
cracks in the child-resistant bottle caps. The medicine is
manufactured by Merck and distributed in the United
States by Merck as TEMODAR. The Temozolomide capsules
(generic) are manufactured and packaged by Merck but sold and
distributed by Sandoz, the authorized generic partner, under the
Sandoz label. In addition to these supplies, Merck also provides
TEMODAR in the United States in sachets (or pouches); TEMODAR in
sachets are not affected.
Merck believes that approximately 1,100 bottles out of an
estimated 276,000 distributed bottles of TEMODAR and Temozolomide
capsules (generic) could potentially have cracked caps. Those
bottles could be at wholesalers, pharmacies, healthcare providers
or with patients. The bottle label will say it is provided by Merck
& Co. or by Sandoz (for the generic). To see pictures of
bottles, please visit www.merck.com and click on “Important Temodar
Information.”
Information for patients
All bottle caps of TEMODAR and Temozolomide capsules (generic)
should be immediately inspected for cracks. If the cap has a crack,
patients should immediately place the bottle out of the sight and
reach of young children. A crack in the bottle cap could render the
closure no longer child resistant. Patients wishing to obtain a
replacement cap, have questions, or who need assistance, should
call the Merck Information Center at 1-800-943-8069. Because the
quality of the medication in the bottles is not affected, patients
may continue to use the drug as directed.
Information for retailers, pharmacies, health care
professional and wholesalers
Retailers, pharmacists and health care professional should also
inspect caps for cracks. Any bottle with a cracked cap should not
be distributed to patients. Wholesalers may return any bottles with
cracked caps if they are observed. For questions, returns, or if
assistance is needed, contact the Merck Information Center at
1-800-943-8069 from 8:00 am to 8:00 pm Eastern Time Monday through
Friday.
“This recall does not relate to the quality or efficacy of the
medicine, and patients can continue taking their medicine. The
patients who use our medicines are our highest priority at Merck,
and we apologize for any inconvenience this situation may cause our
patients and customers,” said Michael Rosenblatt, M.D., executive
vice president and chief medical officer for Merck. “We ask that
anyone in possession of a bottle of TEMODAR or Temozolomide
capsules inspect the bottle caps for cracks. If patients find
cracks in the bottle cap, they can contact us for a replacement,
but they also should immediately ensure that the medicine is out of
sight and reach of children as should always be the case.”
TEMODAR and Temozolomide capsules (generic) are prescription
medicines used to treat adults with certain brain cancer
tumors.
About Merck
Today's Merck is a global health care leader working to help the
world be well. Merck is known as MSD outside the United States and
Canada. Through our prescription medicines, vaccines, biologic
therapies, and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access
to health care through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2014
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150818006351/en/
MerckMedia:Pamela Eisele, 267-305-3558orSkip Irvine,
215-652-6059orInvestors:Justin Holko, 908-740-1879
Merck (NYSE:MRK)
Historical Stock Chart
From Aug 2024 to Sep 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Sep 2023 to Sep 2024