Events

Recall of Dimetapp Saline Nasal Drops for Infants

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Pfizer 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-2014-RN-01036-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01036-1
  • 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
    Pfizer is recalling dimetapp saline nasal drops for infants following a complaint received by tga. the nature of the complaint involved the nozzle of the product becoming dislodged and subsequent flowing of the saline fluid onto a baby’s face.
  • Action
    Retailers and wholesalers are requested to inspect their stock and quarantine all units from the affected batches (21320 and 21465). Retailers are also requested to retain any units returned by consumers and provide a refund or replacement. This action has been closed-out on 18/07/2016.

Device

Dimetapp Saline Nasal Drops for Infants
  • Model / Serial
    Dimetapp Saline Nasal Drops for InfantsBatch numbers: 21320 & 21465ARTG Number: 167019
  • Manufacturer
    Pfizer Australia Pty Ltd

Manufacturer

Pfizer Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DHTGA