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.
