Merck & Co. Recalls Temodar And Temozolomide Bottles With Cracked Caps Due To Failure To Meet Child-Resistant Closure Requirement

WASHINGTON, Aug. 18, 2015 /PRNewswire-USNewswire/ -- http://www.cpsc.gov/en/Recalls/2015/Merck-Recalls-Temodar-and-Temozolomide-Bottles-with-Cracked-Caps

The U.S. Consumer Product Safety Commission is an independent federal agency created by Congress in 1973 and charged with protecting the American public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. To report a dangerous product or a product-related injury, call the CPSC hotline at 1-800-638-2772, or visit http//:www.cpsc.gov/talk.html. Further recall information is available at http://www.cpsc.gov.

Recall Summary

Name of Product: Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules.

Hazard: The bottle cap can be cracked which can cause the child-resistant closure to become ineffective to young children who can gain unintended access to the capsules, posing a risk of poisoning.

Remedy: Replace

Consumers should immediately inspect their bottle caps for cracks. If a crack is found, consumers should contact Merck for a replacement cap. As with all drug products, the bottles should be stored up high, out of sight and reach of young children. Consumers may continue to use the drug as directed.

Consumer Contact: Merck Information Center at 800-943-8069 from 8 a.m. to 8 p.m. ET Monday through Friday, or visit www.merck.com and click on "Important Temodar Information" for more information.

Recall Details

Units: About 276,000

Description: This recall to replace involves bottle caps for Temodar and Temozolomide (generic) capsules, an oral chemotherapy drug. The capsules were distributed in 5- and 14-count brown glass bottles that have white plastic child-resistant caps. A white label affixed to the bottle has the word "Temozolomide" printed in black lettering.

Incidents/Injuries: None reported.

Sold at: Clinics and pharmacies nationwide as a prescribed medicine from July 2013 to August 2015. The container was included in the cost of the medication which is based on quantities prescribed, health insurance terms and other factors.

Manufacturer: Merck Sharp & Dohme Corp., of Whitehouse Station, N.J.

Manufactured in: United States

About U.S. CPSC:
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products under the agency's jurisdiction.  Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical or mechanical hazard. CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters and household chemicals contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 40 years.

Federal law bars any person from selling products subject to a publicly-announced voluntary recall by a manufacturer or a mandatory recall ordered by the Commission.

To report a dangerous product or a product-related injury go online to www.SaferProducts.gov or call CPSC's Hotline at (800) 638-2772 or teletypewriter at (301) 595-7054 for the hearing impaired. Consumers can obtain news release and recall information at www.cpsc.gov, on Twitter @USCPSC or by subscribing to CPSC's free e-mail newsletters.

CPSC Consumer Information Hotline
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/merck-recalls-temodar-and-temozolomide-bottles-with-cracked-caps-due-to-failure-to-meet-child-resistant-closure-requirement-300129937.html

SOURCE U.S. Consumer Product Safety Commission

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