Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules
Class II - Moderate 🏠 Consumer Products
Recalled: August 18, 2015 Merck Sharp & Dohme Corp., of Whitehouse Station, N.J. Clothing & Accessories
Nationwide
What Should You Do?
- Check if you have this product: (About 276,000)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
Recall Details
- Company:
- Merck Sharp & Dohme Corp., of Whitehouse Station, N.J.
- Reason for Recall:
- 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.
- Classification:
- Class II - Moderate
Products that might cause a temporary health problem, or pose a slight threat of a serious nature.
- Status:
- ongoing
- 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.
- 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.
Product Images
Product Information
Full 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 Codes/Lot Numbers:
(About 276,000)
Official Source
Always verify recall information with the official CPSC source:
View on CPSC.govCPSC Recall Number: 15219