Health CanadaGeneral Alert
Pradax (dabigatran etexilate) – Updated Labelling Regarding Kidney Function Assessment and Use in Patients with Certain Types of Heart Valve Disease or Artificial Heart Valves – For the Public
Published: March 21, 2012Recall ID: 48819Category: generalCountry: Canada
Safety AlertHealth CanadaCanada
CanadaPradax (dabigatran etexilate) – Updated Labelling Regarding Kidney Function Assessment and Use in Patients with Certain Types of Heart Valve Disease or Artificial Heart Valves – For the Public
Recalling Firm: Marketed health products
Reason for Recall / Hazard
Labelling
Product Description & Identification
Pradax (dabigatran etexilate) – Updated Labelling Regarding Kidney Function Assessment and Use in Patients with Certain Types of Heart Valve Disease or Artificial Heart Valves – For the Public
Additional Source Details
| Field | Value |
|---|---|
| N I D | 48819 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/pradax-dabigatran-etexilate-updated-labelling-regarding-kidney-function-assessment-0 |
| Issue | Labelling |
| Title | Pradax (dabigatran etexilate) – Updated Labelling Regarding Kidney Function Assessment and Use in Patients with Certain Types of Heart Valve Disease or Artificial Heart Valves – For the Public |
| Archived | 1 |
| Category | Drugs |
| Last updated | 2012-03-21 |
| Organization | Marketed health products |
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Overview
- Recalling FirmMarketed health products
Recall Hazard Severity
Official Agency AlertCaution (Class III)
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🚨 SAFETY ALERT: Marketed health products - Pradax (dabigatran etexilate) – Updated Labelling Regarding Kidney Function Assessment and Use in Patients with Certain Types of Heart Valve Disease or Artificial Heart Valves – For the Public Check if your household is affected: https://therecallfile.com/recalls/pradax-dabigatran-etexilate-updated-labelling-regarding-kidney-functio/CANADA-48819
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