Events

Recall of REFRESH NIGHT TIME and Ircal Eye Ointments

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Allergan 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-00809-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00809-1
  • 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
    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
  • Model / 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