Nombre del producto:
Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules
Riesgo:
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.
Remedio:
Reemplazo
Fecha del retiro:
Agosto 18, 2015
Unidades:
About 276,000
Contacto para los consumidores:

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.

Detalles del retiro

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.

 
Remedio:

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.

Incidentes/Lesiones:

None reported.

Vendido en:

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.

Fabricado por:
Merck Sharp & Dohme Corp., of Whitehouse Station, N.J.
Fabricación en:
Estados Unidos
Número del retiro:
15-219