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Schizophrenia Tablets Recall; Dissolution Test Failure


On June 15, 2017, Teva Pharmaceuticals USA, Inc. recalled one lot of Paliperidone Extended-Release Tablets, 3mg. Paliperidone Extended Release Tablets, 3mg, is indicated for the treatment of schizophrenia and schizoaffective disorders and was distributed nationwide to wholesalers.

 

This recall is being carried out due to failing test results for dissolution. 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.

 

The recalled Paliperidone Extended Release Tablets, 3mg, was distributed nationwide in the United States under the Actavis Pharma Inc. label in 90 count bottles with the lot number 1160682A. The recalled product has an expiration date of June 2018 and an NDC of 0591-3693-19.

 

See the FDA Safety Alert

 

See the Recall

 

See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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