Drug Safety Alerts

Paliperidone Extended-Release 3 mg tablets Consumer-Level Recall

6/15/2017

On June 15, 2017, the United States Food and Drug Administration (FDA) announced that Teva Pharmaceuticals is recalling paliperidone extended-release 3 mg tablets NDC # 00591-3693-19 to the consumer-level. This recall was issued due to failing test results for dissolution. Teva Pharmaceuticals cannot at this time exclude the potential for additional tablets to be below specification.

This recall affects lot number 1160682A exp. 6/2018. The affected lot went into distribution on December 12, 2016.

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.

Please note: This recall was originally issued to the retail-level on June 2, 2017. Teva Pharmaceuticals elevated this recall to the consumer-level on June 15, 2017.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Teva Pharmaceuticals at 1-888-838-2872 and select option 3 then option 4, Monday through Friday, 9:00 am to 5:00 pm (ET). You may also call the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888‑463‑6332) or visit their Web site at https://www.fda.gov.