Cancer Drug Recalled

January 4, 2019

Amerigen Pharmaceuticals Inc. is recalling 3552 bottles of temozolomide capsules, 20 mg, because samples failed to meet dissolution specifications, according to the January 2, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The recalled capsules were manufactured by Stason Pharmaceuticals Inc. and distributed by Amerigen Pharmaceuticals to wholesalers and retailers who may have further distributed the products. The recall affects 5-count bottles of temozolomide capsules (NDC 43975-253-05) from lot 18B005 A and 14-count bottles (NDC 43975-253-14) from lot 18B005 B. Both lots have a February 2020 expiration date.

Amerigen Pharmaceuticals initiated the voluntary recall December 20, 2018. On December 26, 2018, the FDA designated the recall Class III, suggesting use of the recalled drugs is not likely to cause harm.

Temozolomide is a prescription alkylating drug used to slow or stop the growth of cancer cells in the brain.

Jolynn Tumolo

For more Pharmacy Learning Network articles, visit the homepage