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

Merck (MSD), in conjunction with the US Consumer Product Safety Commission (CPSC) have 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 US 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 US in sachets (or pouches); Temodar in sachets are unaffected.

Merck believes that approximately 1100 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).