Merck, a global health care leader, in association with the US Consumer Product Safety Commission (CPSC) asked that all customers, including patients, inspect all bottles of Temodar (temozolomide) capsules and all bottles of Temozolomide capsules (generic) for potential cracks in the child-resistant bottle caps.

Temodar and Temozolomide capsules (generic) are prescription medicines used to treat adults with certain brain cancer tumours. The medicine is manufactured by Merck and distributed in the United States by Merck as Temodar. The Temozolomide capsules (generic) are manufactured and packaged by Merck but sold and distributed by Sandoz, the authorised generic partner, under the Sandoz label. In addition to these supplies, Merck also provides Temodar in the United States in sachets or pouches; Temodar in sachets are not affected.

Merck believes that approximately 1,100 bottles out of an estimated 276,000 distributed bottles of Temodar and Temozolomide capsules (generic) could potentially have cracked caps. Those bottles could be at wholesalers, pharmacies, healthcare providers or with patients. The bottle label will say it is provided by Merck & Co. or by Sandoz (for the generic).

All bottle caps of Temodar and Temozolomide capsules (generic) should be immediately inspected for cracks. If the cap has a crack, patients should immediately place the bottle out of the sight and reach of young children. A crack in the bottle cap could render the closure no longer child resistant.

“This recall does not relate to the quality or efficacy of the medicine, and patients can continue taking their medicine. The patients who use our medicines are our highest priority at Merck, and we apologise for any inconvenience this situation may cause our patients and customers,” said Michael Rosenblatt, M.D., executive vice president and chief medical officer for Merck.

“We ask that anyone in possession of a bottle of Temodar or Temozolomide capsules inspect the bottle caps for cracks. If patients find cracks in the bottle cap, they can contact us for a replacement, but they also should immediately ensure that the medicine is out of sight and reach of children as should always be the case.”