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ISSUE: Teva Pharmaceuticals USA, Inc. (Teva) initiated a voluntary recall to retail-level on 05/31/2017 for one lot of Paliperidone Extended-Release Tablets, 3mg, 90 count bottles, lot 1160682A, expiration 6/2018, NDC 0591-3693-19, that was distributed under the Actavis Pharma Inc. label. In coordination with FDA, Teva is extending this recall to the consumer/user level.
This recall is being carried out due to failing test results for dissolution. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Taking a product for the treatment of schizophrenia and schizoaffective disorders that has failed dissolution could result in less drug being absorbed. 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.
Based on Teva’s investigation, the likelihood of consuming two or more consecutive doses with affected product is low. In addition, no post marketing adverse events have been received to date for lack of effectiveness for this recalled lot.
BACKGROUND: Paliperidone Extended Release Tablets, 3mg is indicated for the treatment of schizophrenia and schizoaffective disorders and was distributed nationwide in the USA to wholesalers.
RECOMMENDATION: Teva has issued an Ur...