Wednesday, May 11, 2011

HIV :Trace Amounts of TBA in 5 Lots of PREZISTA® (darunavir),

Janssen Identifies Trace Amounts of TBA in 5 Lots of PREZISTA®* in Canada and the EU

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TORONTO, May 11 /CNW/ - Janssen Inc. in Canada and Janssen-Cilag International N.V. in Europe today announced the company is engaged in discussions with regulatory authorities in five countries to address trace amounts of TBA (2,4,6 tribromoanisole) identified in five lots of the HIV/AIDS medicine PREZISTA® (darunavir).  The countries affected include Canada, the United Kingdom, Ireland, Germany and Austria.
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. Discussions with regulatory authorities are underway to determine the appropriate course of action in each market.
In Canada, one  lot of 600 mg PREZISTA® tablets was found to contain some bottles with trace amounts of TBA (2,4,6 tribromoanisole). It is estimated that fewer than 300 affected bottles remain in the Canadian marketplace from this lot. In Europe, trace amounts of TBA were found in two lots of 400 mg and two lots of 600 mg tablets.
Patients should continue taking their medication. Anyone in Canada experiencing an uncharacteristic odour associated with PREZISTA® tablets should contact the company at 1-800-567-3331.
PREZISTA® 75 mg and 300 mg are not subject to this action.  Listed below are the five affected lots of PREZISTA® 400 mg and 600 mg tablets:

Package Description Product Code Lot Number Expiry Country

PREZISTA® (darunavir) film-coated TABLETS 600 mg  Bottles of 60 Tablets 62058 ALZ0J00 November
2012 Canada
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 -
AKZ0D00 October 2012 Germany

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1 comment:

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