Following consultation with the TGA, Aspen Pharma Pty Ltd is conducting a sponsor initiated recall of:
Product: SERENACE (haloperidol) 0.5mg tablets
Aust R: 10259
Batch number: BJ431
Expiry date: February 2014
This recall has been initiated because the manufacturer has received reports of tablets from the affected batch with black spots (mould) identified as Penicillium species.
The bottle label identifies Sigma Pharmaceuticals as the Australian sponsor. This batch began distribution on 9th March 2012, and stock is likely to be in circulation.
Please inspect your stocks and quarantine all units from the above batch number for return to your supplier who will arrange for stock to be refunded or replaced. If you have supplies of haloperidol (SERENACE) 0.5mg which have been repackaged by HPS Pharmacies, contact your supplying pharmacy for advice regarding its suitability for continuing use. Any items from this batch supplied by HPS Pharmacies should be returned to the Pharmacy for processing.
Check also any supplies allocated to patients.
No other batches of SERENACE 0.5mg tablets are affected and are available, so HPS Pharmacies do not expect any interruption of supply.
Please retain this notice in a prominent position for one month in case stock is in transit, including other related business units. No other products are affected by this recall.
Should you require further information regarding this matter, please do not hesitate to contact your pharmacist at HPS Pharmacies or Aspen Pharma on 1300 659 646.
Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.