Roche Products Pty Ltd—Viracept (nelfinavir)250 mg tablets, 50 mg oral powder

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

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.

Product category

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