| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01213-1 |
| Product Name/Description |
STALORAL and PHOSTAL
STALORAL (range of sublingual solutions of allergen extracts for allergen immunotherapy)
Multiple Product Codes and Lot/batch numbers affected
PHOSTAL (European Dust Mite (D. Pteronvssinus) suspension for injection
Product Code: 400007276
Lots numbers: 2000277946 & 2000577822 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Stallergenes Australia is recalling the above medicines shipped from the Stallergenes Antony (France) plant after August 13, 2015. This decision has been made after identification by the French health authority, 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. This issue has 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. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stellergenes Australia is advising users to return any unsed stock to the wholesaler for return to Stallergenes. For further information, please see http://www.tga.gov.au/alert/staloral-and-phostal This action has been closed-out on 05/09/2016. |
| Contact Information |
Stallergenes Australia
1800 500 499 - Prescriber Only
1800 635 306 - Patients Only |