Prezista
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 recall | 2 |
| BASG reference number | INS-640.001-0121 |
Further inquiry note
Page last modified:
12/07/2022