Events

Retiro De Equipo (Recall) de REFRESH NIGHT TIME and Ircal Eye Ointments

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Allergan Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00809-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00809-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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