Events

REFRESH NIGHT TIME and Ircal Eye Ointments 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Allergan 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-00809-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00809-1
  • 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
    Allergan initiated this recall based on a small number of customer complaints regarding small black particles associated with the packaging of the product. this black particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminium tube, and potentially introduced into the ointment. if the particle gets into the eye, potential adverse events may include eye pain, eye swelling, ocular discomfort or eye irritation.
  • 조치
    Allergan Australia Pty Ltd is advising the consumers, pharmacists and wholesalers to inspect their stock and immediately quarantine all the affected stock. Consumers will be offered a full refund for any affected product returned by them. Pharmacies have been requested to return their recalled stock to their wholesaler. Allergan Australia will coordinate the return transport from wholesalers and issue credit for the returned stock. This action has been closed-out on 06/09/23016.

Device

REFRESH NIGHT TIME and Ircal Eye Ointments
  • 모델명 / 제조번호(시리얼번호)
    REFRESH NIGHT TIME and Ircal Eye OintmentsIrcal 2 x 3.5 g Ointment Batch Number: 86908 (Exp: 12/17)REFRESH NIGHT TIME 3.5 Ointment Batch Numbers: 85422 (Exp: 06/17), 86516 (Exp: 09/17), 87052 (Exp: 11/17), 87437 (Exp: 02/18)REFRESH NIGHT TIME 2 x 3.5g Ointment Batch Numbers: 84683 (Exp: 04/17), 85422 (Exp: 06/17), 85432 (Exp: 06/17), 86514 (Exp: 9/17), 86934 (Exp:12/17)ARTG Number: 187407
  • Manufacturer
    Allergan Australia Pty Ltd

Manufacturer

Allergan Australia Pty Ltd