Events

Recall of Device Recall Onpharma

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Valeant Pharmacueticals International.

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
    73678
  • Event Risk Class
    Class 2
  • Event Number
    Z-1699-2016
  • Event Initiated Date
    2016-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144726
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    unknown device name - Product Code N/A
  • Reason
    It has been determined that the onset mixing pen has an optimal use period of 18 months from start of use. however, the current labeling and ifu does not stipulate this time period.
  • Action
    Valeant sent a letter entitled "Field Correction to Orapharma Onset Mixing Pen," dated 1/29/2016, to customers via UPS. The letter identified the affected device and the issue involved. The firm recommends that users stop using the device if it had been in use for more than 18 months. Customers were to refer to the list of the affected lots to determine if their device needed to be replaced. If the device was one of the ones identified, users were to contact Valeant Pharmaceuticals to arrange for a replacement at no charge. Questions should be directed to customer service 800-321-4576.

Device

Device Recall Onpharma
  • Model / Serial
    Dosing Mechanism Lot Entry 14090 14452 17133 18004 18403 18583 18757
  • Distribution
    Nationwide Distribution
  • Product Description
    Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. || Manufactured for Onpharma Inc. Los Gratos, CA 95030 || The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.
  • Manufacturer
    Valeant Pharmacueticals International

Manufacturer

Valeant Pharmacueticals International
  • Manufacturer Address
    Valeant Pharmacueticals International, 400 Somerset Corporate Blvd, Bridgewater NJ 08807-2867
  • Source
    USFDA