CPSC official recall · 15219

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

召回日期:2015-08-18官方最后发布:2015-08-19适用地区:美国
重要:以下安全事实保留 CPSC 官方英文原文,避免翻译改变含义。请通过右侧官方公告确认行动要求。

危险说明 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.

受影响产品

Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules
Units:About 276,000

官方描述 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.

事故与伤害 Incidents / Injuries

  • None reported.

官方补救措施 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.

Options:Replace

消费者联系信息

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.

相关企业

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

制造国家/地区:United States

零售商: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.