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
See a list of details to help identify the product
Reason 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.
Details to help identify the product
Supplier running the recall
Roche Products Pty Ltd
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2007/9322 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.