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

Active Recall Announced August 18, 2015 CPSC #15219

Quick answer

Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child-Resistant Closure Requirement is CPSC recall #15219, announced on August 18, 2015. The CPSC cites the following hazard: 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. The remedy is 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.. Affected brand: Merck Sharp & Dohme Corp..

Hazard

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.

Affected products

Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules

Recalled brands

Merck Sharp & Dohme Corp.

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.

Recall date

August 18, 2015

Categories

Tablet or Capsule Drugs

Frequently asked questions

What is CPSC recall #15219?

CPSC recall #15219 covers Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child-Resistant Closure Requirement, announced by the U.S. Consumer Product Safety Commission on August 18, 2015. The CPSC cites the following hazard: 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 is the remedy for recall #15219?

The CPSC remedy for recall #15219 is 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.. Consumers should stop using the product and follow the instructions in the official CPSC notice.

I sell this product on Shopify. What do I need to do?

If you sell Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child-Resistant Closure Requirement on Shopify, stop selling the affected units immediately, notify customers who purchased them, and consider whether you have a Section 15(b) reporting obligation to the CPSC. RecallDocket helps Shopify merchants identify affected SKUs and prepare the required safety report.

Where is the official CPSC notice for this recall?

The primary source is the official CPSC notice at https://www.cpsc.gov/Recalls/2015/Merck-Recalls-Temodar-and-Temozolomide-Bottles-with-Cracked-Caps. RecallDocket links to it from this page.

Not legal advice. RecallDocket aggregates publicly available recall information from the U.S. Consumer Product Safety Commission for informational purposes only. For the official notice, remedy instructions, and any safety actions, refer to the CPSC source. Information may be incomplete or out of date.

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