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Citing failure to meet child-resistant closure requirement, Merck has advised that all bottles should be examined for cracks and that affected bottles should be kept out of children’s reach.
Merck, known as MSD outside the United States and Canada, has issued a recall of its cancer drug, temozolomide, citing cracks found in the bottle cap that could render the closure as no longer child resistant.
The company has alerted the public about the potential failure to meet child-resistant closure requirement for Temodar, manufactured and distributed by Merck in the US, and the generic temozolomide capsules, which are manufactured and packaged by Merck but sold and distributed by generic partner Sandoz, under the Sandoz label. Temodar sachets are not affected, according to Merck. The drug is used to treat certain brain tumors in adults.
It is believed that approximately 1100 bottles out of an estimated 276,000 distributed bottles of Temodar and the generic temozolomide capsules could potentially be affected. Merck has advised that all bottle caps of Temodar and temozolomide be inspected for cracks immediately. These bottles with cracked caps could be at wholesalers, pharmacies, healthcare providers, or with patients. The bottle label will state that it is provided by Merck & Co. or by Sandoz (for the generic drug). Pictures of bottles can be found at Merck’s website.
Merck, however, says that the quality of the medication in the bottles is not affected; patients may, therefore, continue to use the drug as directed. Any bottles found with cracked caps should, however, be kept out of sight and reach of children.