Events

Recall of STALORAL and PHOSTALSTALORAL (range of sublingual solutions of allergen extracts for allergen immunotherapy)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stallergenes Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01213-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-12-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01213-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

STALORAL and PHOSTALSTALORAL (range of sublingual solutions of allergen extracts for allergen imm...
  • Model / Serial
    STALORAL and PHOSTALSTALORAL (range of sublingual solutions of allergen extracts for allergen immunotherapy) Multiple Product Codes and Lot/batch numbers affectedPHOSTAL (European Dust Mite (D. Pteronvssinus) suspension for injectionProduct Code: 400007276Lots numbers: 2000277946 & 2000577822
  • Manufacturer
    Stallergenes Australia Pty Ltd

Manufacturer

Stallergenes Australia Pty Ltd