Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules
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. [Learn More]
About 276,000 units were affected by this recall.
Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child-Resistant Closure Requirement
Temodar® (Temozolomide).
Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules Recall Information
| Country of Origin | United States |
| Recall Date | 08/18/2015 |
| Recall ID | 6483 |
| Recall Number | 15219 |
| Product Type | Tablet or Capsule Drugs |
| 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. |
| 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. |
| Remedy Option | Replace |
| 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. |
| Last Updated | 08/19/2015 |
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