November 25, 2020
Apotex Corp. is recalling two lots of 15-mg aripiprazole tablets because they tested out of specification for dissolution, according to the November 25, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 1000-count bottles (NDC 60505-2675-8) from lot PZ6716 (Exp. 2/21), as well as 30-count bottles (NDC 60505-2675-3) from lot PZ6715 (Exp. 2/21). The affected aripiprazole tablets were distributed throughout the United States.
Apotex Corp. voluntarily initiated the recalls on November 11, 2020. On November 24, 2020, the FDA designated them Class II. Using medications affected by Class II recalls could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Aripiprazole is a prescription antipsychotic medication used to treat patients with bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder. It can also be used with other medication to treat depression.