Paliperidone Manufacturer Issues Urgent Recall

Caroline Cassels

June 15, 2017

Teva Pharmaceuticals has initiated a voluntary recall of a single lot of paliperidone extended-release tablets because it failed test results for dissolution, which could reduce its efficacy. The drug is used to treat schizophrenia and schizoaffective disorders.

On May 31, the manufacturer recalled to retail-level one lot of Paliperidone Extended-Release Tablets — 3-mg, 90-count bottles, lot 1160682A, expiration 6/2018, NDC 0591-3693-19, distributed under the Actavis Pharma, Inc, label. In coordination with the US Food and Drug Administration (FDA), Teva is extending this recall to the consumer/user level.

However, in a release, Teva said it 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 exist with an affected product, 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, and aggressive behavior, as well as vocal and motor tics.

Based on its investigation, the drug company reports that the likelihood of consuming two or more consecutive doses with the affected product is low. In addition, no postmarketing adverse events have been received to date regarding lack of effectiveness for this recalled lot.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and adverse Event Reporting Program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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