CPSC Recalls

Recalls / 2015-08-18

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

15219 · Recalled 2015-08-18 · CPSC page

Temodar® (Temozolomide)
Temodar® (Temozolomide)

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.

Hazards

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.

Reported injuries

None reported.

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.

Products

NameModelUnits
Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsulesAbout 276,000

Parties

Manufacturer
Merck Sharp & Dohme Corp.
Made in
United States
Sold at
Clinics, pharmacies nationwide as a prescribed medicine, health insurance terms, other factors.

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.

More images

Close up view of the Temozolomide Capsules cracked cap rendering the child-resistant closure ineffective
Close up view of the Temozolomide Capsules cracked cap rendering the child-resistant closure ineffective

Source: CPSC recall 15219. Inclusion in this database is not legal or medical advice.