Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child-Resistant Closure Requirement
Recall 15219 · Aug 18, 2015 · Merck
276,000
units affected
276,000
units affected
Facts
- Recall number
- 15219
- Date
- Aug 18, 2015
- Company
- Merck
- Units affected
- 276,000
- Product
- Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules
- Product type
- Tablet or Capsule Drugs
- Remedy
- Replacement
- Hazard
- Poisoning
The product
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.
What can happen
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.
The fix
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.
Incidents and where it was sold
- Incidents
- None reported.
- 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.
Related pages
Questions and answers
What should I do with the recalled bottles with cracked caps containing temodar® (temozolomide) and temozolomide (generic) capsules?
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.
What is the 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.
A recall means the maker found a safety problem and offers a free fix; it does not mean every unit has the problem. Units affected are as reported by the company. Popular models sell more and so have more recalls and complaints. Official public data; texts are shortened. Contact the company named above for the remedy.