Merck is recalling about 276,000 bottles of Temodar and generic temozolomide, after it was determined that some bottles of the cancer drug may have cracked caps, which could allow children access.
The Temodar and Temozolomide (generic) bottle recall was announced by Merck and the U.S. Consumer Product Safety Commission (CPSC) on August 18. The recall came after Merck realized that hundreds of the bottles had cracked child-resistant bottle caps that could allow children access to the potent drugs inside, resulting in poisoning.
Merck and the CPSC are asking all customers, including patients, pharmacists and health care professionals, to inspect all bottles of Temodar and generic temozolomide capsules for potential cracks. If the cap is cracked the bottles should be removed from any potential access by children immediately. No incidents of child poisoning have been reported.
“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,” Merck said in a press release. “Those bottles could be at wholesalers, pharmacies, healthcare providers or with patients.”
The side effects of Temodar, a powerful cancer-fighting drug, can include:
- A potentially fatal allergic skin reaction known as Stevens-Johnson Syndrome (SJS)
- Increased risk of infection
- Dry cough
- Pain while urinating
- Hair loss
The recall affects about 276,000 five and 14-count bottles of Temodar and Temozolomide (generic) capsules, distributed in brown class bottles with white plastic child-resistant caps. The affected drugs were sold as a prescription medication at clinics and pharmacies from July 2013 to August 2015.
Both were manufactured by Merck, but the generic temozolomide capsules were distributed by Sandoz.
The CPSC recommends that consumers with cracked bottle caps contact Merck for a replacement cap and store the drugs high, out of sight and out of reach of young children. Consumers with questions can contact the Merck Information Center by calling (800) 943-8069.