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

May 12th, 2011 // 12:19 pm @

The Company is Working With Regulatory Authorities

High Wycombe, UK – (May 11 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.

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Janssen initiated discussions with regulatory authorities after receiving four consumer reports of an uncharacteristic (“musty, mouldy”) odour. The company’s investigation determined that the odour is 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 – estimated to be fewer than 2,000 in total 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 odour associated with PREZISTA® 400mg or 600mg 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® 400mg is only affected. PREZISTA® 75mg, 150mg and 300mg are not subject to this action.


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