Events

Rappel de REFRESH NIGHT TIME and Ircal Eye Ointments

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Allergan Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00809-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00809-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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