PRA number
2007/9322
Published date
Product description
Viracept 250 mg tablets (300 tablets) AUST R 77222 all batches
Viracept 50 mg oral powder (144g) AUST R 60321 all batches
Viracept 50 mg oral powder (144g) AUST R 60321 all batches
Reasons the product is recalled
Possible contamination of the active substance by an impurity called methane sulfonic acid ethyl ester in the active substance.
The hazards to consumers
Potentially life threatening or could cause a serious risk to health.
What consumers should do
Letters were dispatched to treating specialist physicians, pharmacies linked to HIV clinics, HIV Patient Advocacy Groups and wholesalers.
Supplier
Roche Products Pty Ltd
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.