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Staloral and Phostal
Recall - potential incorrect labelling
Consumers and health professionals are advised that Stallergenes Australia, in consultation with the TGA, is recalling certain batches of Staloral and Phostal.
Staloral is a range of sublingual solutions and Phostal is a suspension for injection. Both medicines are used for allergen immunotherapy. Staloral is for a range of allergens and the affected batch of Phostal is used specifically for European dust mite (D.Pteronyssinus).
This recall follows a directive from the French health authority, Agence Nationale de Sécurité du Médicament (ANSM), to temporarily suspend manufacturing and distribution of pharmaceutical products and active ingredients for use in pharmaceutical products from the Stallergenes production plant in Antony (France), commencing 2 December 2015. Subsequently, the TGA have cancelled the manufacturing clearance for this site.
This decision was made after identification by ANSM that the implementation of a new IT system on 13 August 2015 could lead to these medicines having incorrect labelling that could result in incorrect dosing. It also caused operational disruptions and supply shortages. Any medicines manufactured before 13 August 2015 are not affected and can be used.
If the dosage for these medicines is incorrect, there is a potential for inadequate treatment, excessive dosage and/or allergic reaction.
As of 16 December 2015, there have been no reports of adverse events in Australia or outside of France associated with this issue.
The affected name/description and lot numbers are:
|Product code||Product name/description||Batch no. start||Batch no. end|
|A400007256||5 GRASSES MIX||A315141701||A325366501|
|A400007257||5 GRASSES MIX||A315200501||A325325801|
|A400007263||5 GRASSES MIX||A315466901||A325440801|
|A400007264||5 GRASSES MIX||A315849301||A325724401|
|A400007265||12 GRASSES MIX||A315229101||A325713901|
|A400007266||12 GRASSES MIX||A316230401||A324831401|
|A400007271||5 GRASSES MIX||A315248101||A325646501|
|A400008215||3 GRASSES MIX||A316999601|
|A400008216||5 GRASSES MIX||A319237901|
|A400008686||3 GRASSES MIX||A320570001|
|A400008728||3 GRASSES MIX||A325357201|
|A400009115||5 GRASSES MIX||A323998001|
|A400009459||3 GRASSES MIX||A323478901||A324040701|
- Product name/description - D.Pteronyssinus
- Lot numbers - 2000277946 and 2000577822
Information for consumers
Health professionals who have prescribed/delivered Staloral or Phostal from one of the affected batches will contact those patients and provide further information about this issue. In some cases, Stallergenes Australia will contact patients directly.
If you or someone you care for is taking Staloral or Phostal from an affected batch (see product codes and lot numbers in the section above), stop using it and return it to the doctor or pharmacy where you obtained it as soon as possible. Refunds will be provided for all returned medicine from the affected batches.
If you have any questions or concerns about this issue, speak to your health professional. Alternatively, you can call Stallergenes Australia on 1800 635 306.
Information for health professionals
Stallergenes Australia has contacted health professionals who have prescribed/delivered Staloral or Phostal from the affected batches providing further information about this issue, including details regarding the recall process.
If you have prescribed Staloral or Phostal from one of the affected batches, contact those patients and advise them of this issue. Instruct them to stop taking the medicine and to return any unused product to you or to the pharmacy where they obtained it as soon as possible.
If you have any questions or concerns about this issue, contact Stallergenes Australia on 1800 500 499 (prescriber-only number).
Consumers and health professionals are encouraged to report problems with medicines or vaccines. 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.