Serenace 0.5mg tablet bottle (containing haloperidol)
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Medicine recall
18 September 2012
| Level: | Consumer |
|---|---|
| Class: | I |
| Reference: | RC-2012-RN-00928-1 |
| Date agreed: | 13 September 2012 |
| Product: | Serenace 0.5mg tablets (containing haloperidol) |
| ARTG number: | 10259 |
| Batch number: | BJ431 |
| Expiry | February 2014 |
| 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. |
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.
Content last updated: Tuesday, 18 September 2012
Web page last updated: Friday, 21 September 2012
URL: http://www.tga.gov.au/safety/recalls-medicine-serenace-120918.htm