Recall of ACTIQ 600 μg tablet

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by CEPHALON France.

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
  • Date
    2003-04-11
  • Event Country
  • Event Source
    ANSM
  • Event Source URL
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    CEPHALON France specifies that the recall is requested to the patient, for the therapeutic units of ACTIQ 600 μg, tablet with oral applicator of lot P31366. This precautionary measure is taken in view of the uncertainty regarding the dosage of the active ingredient and because of the total traceability by the hospital pharmacies of the distribution of this narcotic. Given the small number of recipients (5 hospitals), they were informed directly.

Device

  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer

Manufacturer

  • Source
    LAANSM