Drug Recall

 

Subsequent to DrugAlert Volume 134, Boehringer Ingelheim Pty Ltd has now issued a recall notice for:

Product:

SIFROL (pramipexole HCI) tablets

Dose:

0.125 mg

0.25 mg

1 mg

Aust R:

67238

66484

66485

Batch Numbers:

105927

104205

104206

104145

104877

105313A

104688

104878

107242

105927

106323

201880

106321

106886

202900

107241

106886A

203221

108002

107243

108173

107244

201774

108432A

202581

108174A

201429

201776

201429

202632

203020

106703

 

The Consumer Medicine Information (CMI) leaflet inserted into the packet, and in general distribution for SIFROL (pramipexole HCl) tablets contains incomplete dosing advice in the “How to take Sifrol” section under the sub-heading “How much to take”.

The revised CMI for SIFROL tablets shows a revision date of September 2012 at the end of the document and is available for download from medicines.org.au.

SIFROL tablets are safe to used and not subject to recall at this time. SIFROL ER tablets (pramipexole HCl extended release formulation) are not affected by this notice.

Please retain this notice in a prominent position until the recall notice is issued, including other related business units.

Should you require further information regarding this matter, please do not hesitate to contact your pharmacist at HPS Pharmacies or Boehringer Ingelheim on 1800 226 315.

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.

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