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

 

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


Replacement Caps for Patients Are Available

Medication Within the Bottles Is Not Affected; Patients May Continue to Take Their Medicine as Prescribed

 


Merck, known as MSD outside the United States and Canada, in conjunction with the U.S. Consumer Product Safety Commission (CPSC) 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). To see pictures of bottles, please visit www.merck.com and click on “Important Temodar Information.”

Information for patients

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. Patients wishing to obtain a replacement cap, have questions, or who need assistance, should call the Merck Information Center at 1-800-943-8069. Because the quality of the medication in the bottles is not affected, patients may continue to use the drug as directed.

Information for retailers, pharmacies, health care professional and wholesalers

Retailers, pharmacists and health care professional should also inspect caps for cracks. Any bottle with a cracked cap should not be distributed to patients. Wholesalers may return any bottles with cracked caps if they are observed. For questions, returns, or if assistance is needed, contact the Merck Information Center at 1-800-943-8069 from 8:00 am to 8:00 pm Eastern Time Monday through Friday.

“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, 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.”

TEMODAR and Temozolomide capsules (generic) are prescription medicines used to treat adults with certain brain cancer tumors.

For more information, visit www.merck.com