Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
| Level: | Consumer |
|---|---|
| Class: | I |
| Reference: | RN-2007-0376 |
| Date agreed: | 08 June 2007 |
| Product: | VIRACEPT (nelfinavir) 250 mg TABLETS (300 TABLETS) VIRACEPT (nelfinavir) 50 mg/g ORAL POWDER (144g) |
| ARTG number: | AUST R 77222 AUST R 60321 |
| Batch number: | All batches |
| Sponsor: | Roche Products Pty Limited |
| Contact: | Roche Medical Information 1800 233 950 |
| Reason: | The recall has been initiated because of possible contamination of the active substance by an impurity called methane sulfonic acid ethyl ester in the active substance. |
ADVICE TO PATIENTS: - please urgently contact your treating physician with regard to switching to an alternative treatment regimen.
Letters were dispatched to treating Specialist physicians, Pharmacies linked to HIV clinics, HIV Patient Advocacy Groups and wholesalers on 8 June 2007.
Additional information is also being posted on the Roche Website.
Classification system:
Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.
Class I & II recalls are considered to be safety related recalls.