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CPSCRecalled Aug 18, 2015 · #15219

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

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.

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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.

Product details

Product
Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules
Type
Tablet or Capsule Drugs
Manufacturer
Merck Sharp & Dohme Corp., of Whitehouse Station, N.J.
Model numbers
UPCs
Sold at
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.
Made in
United States

What you should do

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.

View the official CPSC notice