The affected product has Lot #1160682A and an expiration date of 6/2018. It was distributed under the Actavis Pharma Inc. label between December 12, 2016 to March 16, 2017 in 90-count bottles; the company reported 360 bottles were sold.
Paliperidone is an atypical antipsychotic indicated for the treatment of schizophrenia and schizoaffective disorders. Consuming a drug that has failed dissolution can lead to reduced drug absorption. If two or more consecutive doses include the affected product, therapeutic levels may not be maintained and may result in a resurgence of symptoms (eg, suicidal thoughts/behavior, self-injurious behavior, mental hospitalizations, assaults, aggression, vocal/motor tics).
To date, no post-marketing adverse events have been reported with regards to lack of efficacy associated with the recalled lot.
Adverse events or quality complaints may be reported to the Food and Drug Administration (FDA)’s MedWatch Adverse Event Reporting program.
For more information call (888) 838-2872 or visit TevaPharm.com.