Replacement | Medicines | 08/09/2011

The marketing authorization holder informed its supplied customers in a letter dated 07.09.2011 that due to individual reports of an unpleasant, moldy odor, a further batch must be recalled. This odor emanates from the primary packaging (plastic bottles) and is due to contamination with traces of 2,4,6-tribromoanisole (TBA).

TBA is a degradation product of 2,4,6-tribromophenol (TBP), which is used among other things for wood treatment, and entered the production chain via wooden pallets used to store and transport the plastic bottles.

Name of the medicinal product Prezista 400 mg Filmtabletten
Marketing authorisation number(s) EU/1/06/380/003
Marketing authorisation holder Janssen-Cilag International NV, BE

Durchführung Austausch:
Janssen-Cilag Pharma GmbH, AT
Batch number(s) ALZ0A00
Classification of the recall2
BASG reference number INS-640.001-0121

Further inquiry note