J&J to Recall Select Lots of Prezista Due to Possible TBA Contamination - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

J&J to Recall Select Lots of Prezista Due to Possible TBA Contamination


ePT--the Electronic Newsletter of Pharmaceutical Technology

Janssen-Cilag International, part of Johnson & Johnson (J&J) is working with regulatory authorities in five countries to address the trace amounts of 2,4,6-tribromoanisole (TBA) that were identified in five batches of the HIV–AIDS medicine Prezista (darunavir). The countries affected include the United Kingdom, Ireland, Germany, Austria, and Canada.

Janssen initiated discussions with regulatory authorities after receiving four consumer reports of an uncharacteristic musty or moldy odor. The company’s investigation determined that the odor was likely caused by trace amounts of TBA found in bottles sourced from a common supplier.

As discussions with regulatory authorities in each of the five countries continue, the company “is committed to recalling and replacing any affected bottles of product remaining in the marketplace,” according to a J&J press release. Janssen estimates that fewer than 2000 bottles have been affected in countries where recalls have been initiated. The action applies to 400- and 600-mg tablets of Prezista. In the UK, only 400-mg tablets of Prezista are affected.

The company and the European Medicines Agency agreed on a Class II recall at the wholesale and retail (i.e., pharmacy) level. Discussions with regulatory authorities in Canada are underway to determine the appropriate course of action. Janssen-Cilag said it does not expect a product shortage to result from the company’s actions to recall and replace affected product.

TBA is a byproduct of a chemical preservative sometimes applied to wood. The chemical is often used in the construction of pallets on which products are transported and stored. While not considered to be toxic, TBA can generate an offensive odor, and patients have reported temporary gastrointestinal symptoms, according to the J&J press release. TBA has caused no reported serious adverse events, according to the company.

In January 2010, Janssen instituted several actions to reduce the potential of TBA contamination, including requiring suppliers to verify that they do not use pallets made from chemically treated wood. An internal investigation is underway with suppliers to evaluate all potential sources of TBA. In addition, Janssen is working with peer companies to better understand how and where TBA is entering and affecting the supply chain.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
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