Some Darunavir Recalled Due to Contamination

SUMMARY
Trace amounts of TBA (2,4,6 tribromoanisole), a preservative and fungicide, were detected in 5 batches of darunavir (Prezista) in Canada and Europe; no contaminated drug was found and no recall is underway in the U.S.

Below is an edited excerpt from a press release issued by Janssen-Cilag International describing the problem and steps the company is taking to correct it.

The full press release, including detailed safety information, is available online at http://www.jnj.com/connect/news/product/janssen-identifies-trace-amounts-of-tba-in-5-batches-of-prezista-darunavir-in-the-eu-and-canada.

Janssen Identifies Trace Amounts of TBA in 5 Batches
of Prezista (darunavir) in the EU and Canada

The Company is Working With Regulatory Authorities

High Wycombe, UK -- 11 May 2011 -- Janssen-Cilag International N.V. today announced the company is working with regulatory authorities in five countries to address trace amounts of TBA (2,4,6 tribromoanisole) 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, mouldy") odor. The company's investigation determined that the odor is likely caused by trace amounts of TBA. 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 -- estimated to be fewer than 2,000 in countries where recalls have been initiated.

Company discussions with the European Medicines Agency resulted in agreement on a Class II recall at the wholesale and retail (pharmacy) level. Discussions with regulatory authorities in Canada are underway to determine the appropriate course of action. The Company does not anticipate a product shortage resulting from the company's actions to recall and replace affected product.

Patients should not stop taking their medication. Anyone experiencing an uncharacteristic odor associated with Prezista 400 mg or 600 mg tablets -- or anyone with questions about the company's actions to recall and replace -- should contact the company at 0800 032 3013 (freephone).

It should be noted that in the UK Prezista 400 mg is only affected. Prezista 75 mg, 150 mg and 300 mg are not subject to this action.

Listed below are the five affected batches of Prezista 400 mg and 600 mg tablets:

Package Description	Product Code	Lot Number	Expiry	Country
Prezista (darunavir) film-coated tablets 400 mg Bottles of 60 tablets	386333	AKZ0B00	October 2012	Germany, Austria
	386471	AFZ0C00	May 2012	United Kingdom, Ireland
Prezista (darunavir) film-coated tablets 600 mg Bottles of 60 tablets	386332	ALZ0E00	October 2012	Germany, Austria
	386332	AKZ0D00	October 2012	Germany
Prezista (darunavir) film-coated tablets 600 mg Bottles of 60 tablets	62058	ALZ0J00	November 2012	Canada

TBA is a byproduct of a chemical preservative sometimes applied to wood 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 a very small number of patients have reported temporary gastrointestinal symptoms. As it relates to Prezista, there have been no reported serious adverse events caused by the presence of TBA.

In January 2010, Janssen instituted a number of 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 impacting the supply chains and what it can do to further mitigate this exposure.

Full prescribing information for Prezista is available at http://www.prezista.com/sites/default/files/pdf/us_package_insert.pdf.

About Janssen

Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving important unmet medical needs, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.

5/13/11

Source
Janssen-Cilag International. Janssen Identifies Trace Amounts of TBA in 5 Batches of Prezista (darunavir) in the EU and Canada. Press release. May 11, 2011.