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

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stallergenes Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2015-RN-01213-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-12-15
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    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

Manufacturer