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

Recall of Venture catheters by Vascular Solutions- Catheter tip may split or separate during use

Read more
  • MedWatch Drug Updates
  • 1 comment

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

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Clindamycin Injection USP ADD-Vantage vials by Alvogen: Presence of microbial growth

Read more
  • MedWatch Drug Updates
  • 1 comment

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

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA safety alert: Navigational accuracy errors associated with frameless stereotaxic navigation systems

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Nitroglycerin Injection in 5% Dextrose USP by Advanced Pharma due to sub-potency

Read more
  • MedWatch Drug Updates
  • no comment

Recall of one lot Eliquis 5 mg tablets by Bristol-Myers Squibb- Contain product of incorrect strength

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of topical products by Phillips Company- Improper manufacturing practices affecting product's quality

Read more
  • MedWatch Drug Updates
  • 1 comment

Drug safety alert: Canagliflozin (Invokana, Invokamet) may increase the risk of leg and foot amputations

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Radicava (edaravone) for amyotrophic lateral sclerosis

Read more
  • MedWatch Drug Updates
  • 1 comment

Use of Medtronic’s NavLock Tracker with non-Medtronic instruments can cause spinal injury or death

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Rydapt (midostaurin) for acute myeloid leukemia

Read more
  • FDA Drug Updates
  • no comment

FDA expands approved use of Stivarga (regorafinib) for liver cancer

Read more
  • FDA Drug Updates
  • no comment

FDA approved Brineura (cerliponase alfa) for Batten disease

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of 25% Dextrose Injection, USP, (Infant) by Hospira- Presence of particulate matter

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators by Zimmer Biomet

Read more
  • MedWatch Drug Updates
  • no comment

Recall of Mibela 24 Fe chewable tablet by Lupin Pharmaceuticals Inc- Packaging error affecting dosing regimen

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of physician sample of Brilinta (ticagrelor) 90mg by AstraZeneca- Presence of another medicine Zurampic

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Ingrezza (valbenazine) for tardive dyskinesia

Read more
  • MedWatch Drug Updates
  • 1 comment

Class I Recall of HeartMate II LVAS Pocket System Controller by Abbott-Thoratec- Controller malfunction after exchange

Read more
  • MedWatch Drug Updates
  • 1 comment

Class I Recall of V60 Non-invasive ventilator by Respironics- Unexpected stop in ventilation therapy

Read more
  • MedWatch Drug Updates
  • 1 comment

Gadolinium-based contrast agent for MRI- No adverse effects reported with gadolinium retention in the brain

Read more
  • MedWatch Drug Updates
  • no comment

Recall of Tri-Ton by Dynamic Technical Formulations LLC- Presence of unapproved drug andarine and ostarine

Read more
  • FDA Drug Updates
  • no comment

FDA approved Ocrevus (ocrelizumab) for multiple sclerosis

Read more
  • FDA Drug Updates
  • 1 comment

FDA approves Dupixent (dupilumab) for atopic dermatitis

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Zejula (niraparib) for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Bavencio (avelumab) for Merkel cell carcinoma

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Xadago (safinamide) for Parkinson’s disease

Read more
  • MedWatch Drug Updates
  • no comment

Safety alert against LeadCare Testing Systems by Magellan Diagnostics due to inaccurate test results

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Coronary Catheters by Abbott due to difficulty in removing the protective balloon sheath

Read more