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Serenace (haloperidol) 0.5mg tablets (Batch number BJ431)

Medicine recall

21 September 2012

Aspen Pharma Pty Ltd, in consultation with the TGA, is undertaking a voluntary consumer level recall of a single batch of Serenace (haloperidol) 0.5 mg tablets due to the presence of mould on a small number of tablets in the batch (Batch number BJ431).

Information for patients

Patients are advised not to take tablets from the affected batch and to return them to their pharmacy for replacement.

There have been no reports of illness as a result of the presence of mould on the tablets.

Patients who have any concerns should talk to their health professional.

How to identify if your medicine is affected

The medicine bottle label contains following information:

  • Sigma Pharmaceuticals
  • AUST R 10259
  • Batch number: BJ431
  • Date of expiry: February 2014

About Serenace (haloperidol) 0.5 mg tablets

Serenace (haloperidol) 0.5 mg tablets are used to treat mental illnesses such as schizophrenia; mania; severe anxiety, tension or excitement and severe agitation, hyperactivity or aggression in patients with mental or emotional illness; and Tourette's Syndrome.

About the recall

Aspen Pharma Pty Ltd, the company supplying the Sigma Pharmaceuticals-branded product, received several complaints from pharmacists of black spots on the surface of Serenace 0.5 mg tablets.

The black spots were identified by the manufacturer as mould (Penicillium species).

Approximately 17,496 bottles of the affected batch (BJ431) have been supplied in Australia, however only a small number of tablets within the batch have been affected. Each bottle contains 100 tablets.

Other batches of Serenace 0.5 mg tablets are not affected by this recall and will continue to be available to patients via a prescription.

Apsen Pharma Pty Ltd has placed advertisements in newspapers to alert consumers and health professionals to the recall.