Recall of Paliperidone Extended-Release tablets, 3mg by Teva Pharmaceuticals due to failure of dissolution test

Access to the full content of this site is available only to registered healthcare professionals. Register to read more

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...

Recommended for you

  • MedWatch Drug Updates
  • 1 comment

FDA update: Type III endoleaks associated with the use of endovascular graft systems

  • MedWatch Drug Updates
  • 1 comment

FDA update: High risk of mortality and neurological adverse events when using SynCardia's TAH-t C2 Driver System

  • MedWatch Drug Updates
  • 1 comment

Class I Recall of Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Blocked guidewire lumen

  • MedWatch Drug Updates
  • 1 comment

Recall of Intralipid 20 % IV Fat Emulsion by Baxter: One lot of product exposed to subfreezing temperature

  • FDA Drug Updates
  • 1 comment

FDA approved Aliqopa (copanlisib) for the treatment of relapsed follicular lymphoma

  • FDA Drug Updates
  • 1 comment

FDA approved Mvasi (bevacizumab-awwb) for the treatment of cancer

  • MedWatch Drug Updates
  • 1 comment

Case of HORV reported after intraocular Inj of a compounded triamcinolone, moxifloxacin, vancomycin

  • MedWatch Drug Updates
  • 1 comment

FDA alert- Not to use infant sleep positioners as it can cause suffocation

  • MedWatch Drug Updates
  • no comment

Class I Recall of Intra-Aortic Balloon Pump by Datascope/MAQUET- False blood detection alarm and ingress of fluid into the pump

  • MedWatch Drug Updates
  • 1 comment

FDA recommends separate dosing for Kayexalate (sodium polystyrene sulfonate) from all other oral drugs

  • MedWatch Drug Updates
  • 1 comment

FDA statement on risks of unapproved use of Keytruda (pembrolizumab) for treatment of multiple myeloma

  • MedWatch Drug Updates
  • 1 comment

Recall of Piyanping Anti-Itch Lotion by Lucky Mart Inc.: Contain wrong active pharmaceutical ingredient

  • FDA Drug Updates
  • no comment

FDA approves Besponsa (inotuzumab ozogamicin) for acute lymphoblastic leukemia

  • MedWatch Drug Updates
  • 1 comment

FDA alert: Incorrect dosing of Ocaliva (obeticholic acid) associated with increased risk of serious liver injury

  • MedWatch Drug Updates
  • 1 comment

FDA advise on use of opioid addiction medication in patients taking benzodiazipines or CNS depressants

  • FDA Drug Updates
  • 1 comment

New targeted treatment approved for relapsed or refractory acute myeloid leukemia

  • MedWatch Drug Updates
  • 1 comment

Class I recall of Penumbra 3D Revascularization device by Penumbra: delivery wire may break or separate during use

  • FDA Drug Updates
  • 1 comment

FDA approved Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Hepatitis C

  • MedWatch Drug Updates
  • 1 comment

Recall of VV28F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical- Extension tube may separate from hub

  • FDA Drug Updates
  • 1 comment

FDA approved Nerlynx (neratinib) for breast cancer

  • MedWatch Drug Updates
  • 1 comment

Recall of Diabetes Infusion Sets by Medtronic -Vent Membrane susceptible to blocking by fluid

  • MedWatch Drug Updates
  • 1 comment

Recall of Baby Organic Liquid Formula by Garden of Life: Misleading direction for use

  • FDA Drug Updates
  • 1 comment

FDA approved Endari (L-glutamine) for sickle cell disease

  • MedWatch Drug Updates
  • 1 comment

Recall of Novopen Echo Insulin Delivery Device by Novo Nordisk: Chemical exposure may damage cartridge holder

  • MedWatch Drug Updates
  • 1 comment

Recall of Atar Extension Cables by Oscor- cable malfunction interrupting the pacing system

  • MedWatch Drug Updates
  • 1 comment

Recall of Activase (alteplase) 100mg by Genentech due to lack of sterility assurance

  • FDA Drug Updates
  • 1 comment

FDA approved Haegarda (C1 esterase inhibitor) for Hereditary Angioedema

  • MedWatch Drug Updates
  • 1 comment

FDA Alert- Not to use Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products

  • MedWatch Drug Updates
  • 1 comment

Recall of Oxytocin compounded with either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium

  • MedWatch Drug Updates
  • no comment

Field Correction of system CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope