Events

Recall of Valeant Pharmaceuticals International

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Valeant Pharmaceuticals North America LLC.

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
    72198
  • Event Risk Class
    Class 2
  • Event Number
    Z-0371-2016
  • Event Initiated Date
    2015-09-14
  • Event Date Posted
    2015-12-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140162
  • 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
    Nebulizer (direct patient interface) - Product Code CAF
  • Reason
    Spag-2 6000 lot j3522070 was released to commerce without being tested for particle size per quality control procedure spag-2515.
  • Action
    Valeant Pharmaceuticals International issued recall letter/return response form dated 9/11/2015 via 2nd day air service Customers were requested to check their inventory for the SPAG-2 device and sgregate it for return shipment.

Device

Valeant Pharmaceuticals International
  • Model / Serial
    Lot #J3522070  Serial numbers 23461 23463 23466 23467 23468 23469 23472 23475 23477 23479 23480 23481 23482 23484 23485 23486 23487 23488 23489 23490 23491 23492 23493 23495 23503 23504 23505 23506 23507 23508 23509 23510 23512 23513 23514 23515 23517 23520 23521 23524 23529 23530 23531 23532 23535 23536 23540 23547 23558 23560 23568 23569 23570 23571 23572 23579 23587 23589 23590 23592 23593
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX
  • Product Description
    Valeant Pharmaceuticals North America Model No. Spag-2 || Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole
  • Manufacturer
    Valeant Pharmaceuticals North America LLC

Manufacturer

Valeant Pharmaceuticals North America LLC
  • Manufacturer Address
    Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd, Bridgewater NJ 08807-2867
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA