Consumers and health professionals are advised that Aspen Pharmacare Australia, in consultation with the TGA, is recalling one batch of its Imigran (sumatriptan) cartridge injections.
Imigran cartridge injections are used to treat migraine and cluster headaches.
The affected batch number is C632305 with an expiry date of May 2015.
A manufacturing fault led to needles protruding through the rubber needle shield in a small percentage of the cartridge injections in this batch. The protruding needle will not be sterile and affected cartridge injections should not be used.
Aspen Pharmacare is the new sponsor of Imigran, but the affected batch is printed with the previous sponsor's details, GlaxoSmithKline (GSK).
No other batches of Imigran injections, tablets or nasal sprays are subject to the recall.
There had been no reports of adverse events related to this issue in Australia as at 7 November 2013.
Information for consumers
If you have a pack of Imigran injection cartridges from batch number C632305 do not use the product.
Return affected Imigran injection cartridges to your pharmacy for refund or replacement.
Aspen Pharmacare is the new sponsor of Imigran, but the packaging of the affected batch is printed with the previous sponsor's details, GlaxoSmithKline (GSK).
If you have any questions or concerns, you can call the Aspen Pharmacare customer service department on 1300 659 646 for further information.
Information for health professionals
If you are treating a patient who may be using the affected batch of Imigran injection cartridges, advise them of this issue. If they do have an affected device, advise them not to use an affected cartridge and to contact their pharmacist for a replacement.
Apen Pharmacare is writing to pharmacists who have supplied Imigran cartridge injections to patients, providing further information about this issue and the recall procedures.
Pharmacists should check their shelves and quarantine any stocks of Imigran cartridge injections from batch no C632305 (expiry date May 2015).
No other batches of Imigran injections, tablets or nasal sprays are subject to the recall. It does not affect the autoinjector pack.
If you or a patient have any questions or concerns about this issue, contact Aspen Pharmacare on 1300 659 64.
Reporting problems
Consumers and health professionals are encouraged to problems with medicines, vaccines or medical devices. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.