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RASFFReference 2025.1071

Presencia de sustancia farmacológica (tadalafilo) en complemento alimenticio//Undeclared presence of pharmacological substance (Tadalafil) in supplement

Official information organised for easier consultation. The source publication remains authoritative.

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RASFF

Identification and classification

Reference
2025.1071
Notification ID
744574
Classification
alert notification
Risk decision
serious
Product type
food
Notification basis
official control on the market
Status
ec_validated

RASFF

Product

Description
Food supplement
Distribution status
Description
product traded online
Notification ID
228
Notification ID
27312578
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    27319068
    productAspect
    Botella plastificada
    temperature
    Description
    ambient
    Notification ID
    27368

RASFF

Risk and analytical results

hazardObserved
Tadalafilo (inhibidor de la fosfodiesterasa-5). Los inhibidores de la PDE-5 están contraindicados en pacientes con infarto agudo de miocardio, angina inestable, angina de esfuerzo, insuficiencia cardiaca, arritmias incontroladas, hipotensión, hipertensión arterial no controlada, historia de accidente isquémico cerebral (ictus isquémico), así como en pacientes con insuficiencia hepática grave y en personas con antecedentes de neuropatía óptica isquémica anterior no arterítica //PDE-5 inhibitors are contraindicated in patients with acute myocardial infarction, unstable angina, exertional angina, heart failure, uncontrolled arrhythmias, hypotension, uncontrolled hypertension, history of cerebral ischaemic stroke (ischaemic stroke), as well as in patients with severe hepatic impairment and in people with a history of non-arteritic anterior ischaemic optic neuropathy.
Notification ID
114741

RASFF

Hazards

  1. Hazard category
    Description
    composition
    Notification ID
    27314919
    Name
    tadalafil - unauthorised substance - composition
    samplingDate
    22-01-2025 00:00:00
  2. analyticalResult
    1400 ± 700
    Hazard category
    Description
    composition
    Notification ID
    28538039
    Name
    tadalafil - unauthorised substance - composition
    samplingDate
    19-03-2025 00:00:00
    unit
    mg/kg - ppm

RASFF

Measures

  1. Action taken
    Description
    public warning - press release
    Notification ID
    18838
    Notification ID
    27314765
    takenBy
    Notification ID
    5010
    isoCode
    ES
    organizationName
    Spain
  2. Action taken
    Description
    withdrawal from the market
    Notification ID
    18837
    Notification ID
    27313860
    takenBy
    Notification ID
    5010
    isoCode
    ES
    organizationName
    Spain

RASFF

Origin, notification and distribution

Origin
Colombia
Notifying country or territory
Spain
Published distribution
product traded online

RASFF

Published territorial roles

  1. Roles
    1. Role
      FOR_ATTENTION
      notificationId
      746615
    2. Role
      ORIGIN
      notificationId
      744574
    3. Role
      OPERATOR
      notificationId
      744574
    Organisation
    code
    CO
    countryNetworkOrganizationId
    5078
    Description
    Colombia
    Notification ID
    10073
  2. Roles
    1. Role
      FOR_ATTENTION
      notificationId
      744574
    Organisation
    code
    INFO
    countryNetworkOrganizationId
    5680
    Description
    INFOSAN
    Notification ID
    10340
  3. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      744574
    Organisation
    code
    NL
    countryNetworkOrganizationId
    5026
    Description
    Netherlands
    Notification ID
    38
  4. Roles
    1. Role
      NOTIFYING
      notificationId
      744574
    2. Role
      NOTIFYING
      notificationId
      763150
    3. Role
      FOR_ATTENTION
      notificationId
      763150
    4. Role
      NOTIFYING
      notificationId
      744574
    5. Role
      OPERATOR
      notificationId
      744574
    Organisation
    code
    ES
    countryNetworkOrganizationId
    5010
    Description
    Spain
    Notification ID
    2

RASFF

Follow-ups

  1. fupDate
    14-02-2025 14:57:21
    fupId
    745003
    fupNumber
    1
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    13501
    organizationCode
    ES
    organizationDescription
    FOOD AESAN
  2. fupDate
    21-02-2025 11:54:04
    fupId
    746615
    fupNumber
    2
    fupType
    Description
    request
    Notification ID
    27665
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  3. fupDate
    12-05-2025 16:34:35
    fupId
    763150
    fupNumber
    3
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    38
    organizationCode
    NL
    organizationDescription
    Netherlands

RASFF

5010
  1. countryNetworkOrganizationId
    5010
    Notification ID
    35
    link
    http://aplicaciones.magrama.es/silum/web/novedades/novedades.jsp
  2. countryNetworkOrganizationId
    5010
    Notification ID
    36

Provenance and context

NagameAlert organises public RASFF data while preserving official values and keeping notification classification separate from the risk decision. The official record remains authoritative and should be checked for follow-ups and current status.