Merck & Co. Inc. a, in conjunction with the US Consumer Product Safety Commission has 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. 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 authorized 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). Temodar and temozolomide capsules (generic) are prescription medicines used to treat adults with certain brain cancer tumors.

“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 apologize for any inconvenience this situation may cause our patients and customers,” said Michael Rosenblatt, MD, executive vice president and chief medical officer for Merck in a company statement. “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.”

Source: Merck & Co