Serenace 0.5mg tablet bottle (containing haloperidol)
18 September 2012
|Date agreed:||13 September 2012|
|Product:||Serenace 0.5mg tablets (containing haloperidol)|
|Sponsor:||Aspen Pharma Pty Ltd. Please note that the bottle label identifies Sigma Pharmaceuticals as the Australian sponsor.|
|Patient information:||Do not use affected batch. Return the affected batch to the pharmacy and arrange for replacement.|
|Contact:||Aspen Pharma Pty Ltd has provided a contact number for consumers with any concerns or questions. The telephone number is 1300 659 646 (select option 2).|
|Reason:||This recall is being conducted because the manufacturer has received reports of tablets from the affected batch with black spots (mould) identified as Penicillium species.|
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.
Content last updated: Tuesday, 18 September 2012
Web page last updated: Friday, 21 September 2012