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Medication Safety Alerts

Temodar® and Temozolomide Capsules Voluntary Recall

8/24/2015

On August 24, 2015, Merck and Company, Inc. issued a voluntary recall of Temodar® capsules distributed by Merck and the generic temozolomide capsules distributed by Sandoz. This recall was issued because of cracks in the child-resistant manufacturer’s bottle caps. If the manufacturer’s original bottle cap is cracked, it may no longer be child-resistant.

Please note: There are no quality or safety concerns with Temodar and/or temozolomide capsules. If you received your medicine in the original manufacturer’s bottle and the bottle cap is not cracked, you may continue to use these products as directed. If you received your medicine in your dispensing pharmacy’s bottle, it is not affected by this recall and is safe to use.

Merck has provided the following instructions for plan members:

  • Visually inspect the caps on all bottles for any cracks in the child-resistant cap.
  • If any cracked caps are found, make sure that the medicine is out of the sight and reach of children. If a bottle cap is cracked, it may no longer be child-resistant.
  • Plan members may continue to use the medicine as directed, as there are no quality or safety concerns with the medicine.
  • If a cracked cap is found, members may call Merck toll-free at 1‑800‑943‑8069 to get a replacement cap.
  • If you have any questions or need assistance, please contact the Merck Information Center toll-free at 1-800-943-8069, Monday through Friday, 8:00 a.m. to 8:00 p.m. (ET).

CVS/caremark Response: Please note: These products are not carried by the CVS/caremark Mail Service Pharmacies.

For more information about this recall, please call Merck Information Center toll-free at 1‑800‑943‑8069, Monday through Friday, 8:00 AM to 8:00 PM (ET) or visit www.merck.com/product/temodar_info.html.

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