Cancer Drug Recalled

Amerigen Pharmaceuticals Inc. is recalling two lots of temozolomide capsules, 5 mg, because samples failed to meet dissolution specifications during testing, according to the February 27, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects 5-count bottles (NDC 43975-252-05) from lot 18J043A (Exp. 9/30/20) and 14-count bottles (NDC 43975-252-14) from lot 18J043B (Exp. 9/30/20). The capsules were distributed to several wholesalers and one retail account that may have further distributed the medication throughout the United States.

Amerigen Pharmaceuticals voluntarily initiated the recall February 19, 2019. The next day, the FDA designated the recall Class III, which suggests use of the affected capsules is unlikely to cause adverse health consequences. 

Temozolomide is a prescription alkylating agent used to treat certain types of brain cancer. 

—Jolynn Tumolo