VIRACEPT (nelfinavir) 250 mg tablets (300 tablets) / VIRACEPT (nelfinavir) 50 mg/g oral powder (144g)
Medicine recall
| Level: | Consumer | Class: | I |
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| Reference: | RN-2007-0376 | Date: | 8 June 2007 |
| Product: | VIRACEPT (nelfinavir) 250 mg TABLETS (300 TABLETS) VIRACEPT (nelfinavir) 50 mg/g ORAL POWDER (144g) |
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| ARTG number: | AUST R 77222 AUST R 60321 |
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| Batch number: | ALL BATCHES | ||
| Sponsor: | Roche Products Pty Limited | ||
| Phone: | 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. | ||
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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 <http://www.roche-australia.com/recall.cfm>. |
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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.