Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child-Resistant Closure Requirement

Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules

Date of Recall

2015-08-18

CPSC Release Number

15-219

Manufactured In

United States

Units

About 276,000

Manufacturer

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

Sold By

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.

Problem/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.

Injuries/Incidents

None reported.

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.

Remedy

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.

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