J&J Issues Voluntary Recall of Risperdal - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

J&J Issues Voluntary Recall of Risperdal

ePT--the Electronic Newsletter of Pharmaceutical Technology

Ortho-McNeil-Janssen, a subsidiary of Johnson & Johnson, initiated a voluntary recall of its antipsychotic medication Risperdal because of an unusual odor. The recall covers one lot of 3-mg Risperdal tablets and one lot of 2-mg risperdone tablets. Risperdone is a generic form of the drug. The Risperdal lot originally contained 16,000 bottles, but the company believes approximately 1600 remain on the market, and believes around 1200 of the original 24,000 risperdone bottles remain. The lot numbers associated with the recall can be found in the company press release.

The odor is caused by small amounts of TBA (2,4,6 tribromoanisole), a chemical associated with preservatives applied to wood and found in shipping pallets used for storing and shipping drugs. TBA is not thought to be toxic, but it produces a musty, moldy odor, and a small number of people has reported temporary gastrointestinal symptoms after exposure to the smell.

This event marks the latest in a string of recalls resulting from odors caused by TBA contamination. Lots of J&J’s anti-HIV drug Prezista were recalled in May, and lots of their anticonvulsant Topomax were recalled in April. The company has been working since January 2010 to minimize the risks of further contamination and now requires suppliers to certify that they do not use pallets made from chemically treated wood.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here