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From Products Liability Law Daily, August 18, 2015

Merck recalls 276,000 chemotherapy drug bottles with cracked caps over poisoning risk

By John Dumoulin

Merck Sharp & Dohme Corp., of Whitehouse Station, New Jersey, has recalled approximately 276,000 bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules because 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 (CPSC Recall Notice, No. 15-219, August 18, 2015).

Incidents and injuries. No incidents or injuries have been reported.

Product 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.

The containers, which were included in the cost of the medication, were manufactured in the United States. They were sold at clinics and pharmacies nationwide from July 2013 to August 2015, and the cost was based on quantities of the medication prescribed, health insurance terms, and other factors.

Remedy. Consumers should inspect their bottle caps for cracks immediately. 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.

Customer contact. For more information, customers may contact Merck Information Center at 800-943-8069 from 8 a.m. to 8 p.m. ET Monday through Friday, or visit and click on “Important Temodar Information.”

Companies: Merck Sharp & Dohme Corp.

MainStory: TopStory ChildrensProductsNews DrugsNews

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