Mylan Recalls Four Doses of Brain-Tumor Drug
Mylan has issued a voluntarily Class II recall of four dosage forms of temozolomide capsules, a chemotherapy brain-tumor drug. Mylan initiated the recall in December 2016 for the 100-mg, 140-mg, 180-mg, and 250-mg dosage forms due to failed tablet/capsule specification in which broken or crushed capsules that resulted in loose powder were found in some bottles. The recall was noted by the US Food and Drug Administration (FDA) on January 25, 2017.
A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, according to the FDA.
The recall applies to a total of 4,191 prescription-only bottles packaged in 5-count and 14-count bottles: 1,813 bottles for the 100-mg dosage form; 1,334 bottles for the 140-mg dosage form; 456 bottles for the 180-mg dosage form; and 588 bottles for the 250-mg dosage form. The temozolomide capsules were made in Mylan’s facility in Morgantown, West Virginia.
Mylan’s temozolomide capsules are the generic version of Merck & Co.’s chemotherapy drug, Temodar (temozolomide), which was approved by the FDA in 1999 and is indicated for treating newly diagnosed glioblastoma mulitforme and refractory anaplastic astrocytoma.