Teva Recalls Schizophrenia Drug Due to Dissolution Failure

Teva Pharmaceuticals has recalled one lot of paliperidone extended-release tablets, 3mg, 90 count bottles (lot 1160682A), which was distributed under the Actavis Pharma Inc. label, due to failing test results for dissolution. Teva says it cannot at this time exclude the potential for additional tablets to be below specification and potentially recalled. “Taking a product for the treatment of schizophrenia and schizoaffective disorders that has failed dissolution could result in less drug being absorbed,” a recall notice says. “If two or more consecutive dosing regimens are with affected product, a failure to maintain therapeutic levels could occur, which could reduce effectiveness in treating a patient’s mental and/or mood symptoms, including suicidal thoughts and behavior, self-injurious behavior, mental hospitalizations, assaults, aggressive behavior, as well as vocal and motor tics.”