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RASFFReference 2023.2512

Sildenafil and sibutramine presence in dietary food supplements from Turkey

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

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RASFF

Identification and classification

Reference
2023.2512
Notification ID
606539
Classification
information notification for attention
Risk decision
serious
Product type
food
Notification basis
official control on the market
Status
ec_validated

RASFF

Product

Description
TREX TEA ; TREX CAPS and TREX PLUS
Distribution status
Description
information on distribution not (yet) available
Notification ID
221
Notification ID
19747205
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    19747338
    labelling
    Refresh yourself
    productAspect
    Coffret en carton de 60 sachets de TREX TEA en poudre
    temperature
    Description
    ambient
    Notification ID
    27368
  2. Notification ID
    19747341
    productAspect
    Boîte de 30 gélules
    temperature
    Description
    ambient
    Notification ID
    27368
  3. Notification ID
    19747348
    productAspect
    tube de comprimés effervescents
    temperature
    Description
    ambient
    Notification ID
    27368

RASFF

Risk and analytical results

hazardObserved
Sibutramine is a drug that was marketed in France between 2001 and 2010 under the name Sibutral, as a treatment for obesity. During this period, a significant number of serious undesirable effects, in particular cardiovascular, were reported. The European Drugs Agency's analysis of the benefit/risk ratio led to the suspension of its marketing authorisation. The drug has been forbidden since 2010. Sildenafil (Viagra and generics) is a drug indicated for erectile dysfunction and can cause potentially serious side effects: headache, flushing, digestive disorders, nasal congestion, dizziness, nausea, visual disturbance, etc.
Notification ID
83241
numberOfPersonsAffected
19
typeOfIllness
● heart rhythm disorders, hypertension, tachycardia, palpitations, thoracic pain. ● sleep disorders, dizziness, anorexia, headaches, epileptic fits.

RASFF

Measures

  1. Action taken
    Description
    prohibition to trade - sales ban
    Notification ID
    18953
    Notification ID
    19747357
    takenBy
    Notification ID
    5013
    isoCode
    FR
    organizationName
    France
  2. Action taken
    Description
    recall from consumer
    Notification ID
    18836
    Notification ID
    19747436
    takenBy
    Notification ID
    5013
    isoCode
    FR
    organizationName
    France

RASFF

Origin, notification and distribution

Origin
Türkiye
Notifying country or territory
France
Published distribution
information on distribution not (yet) available

RASFF

Published territorial roles

  1. Roles
    1. Role
      NOTIFYING
      notificationId
      606539
    2. Role
      NOTIFYING
      notificationId
      606539
    3. Role
      FOR_FOLLOW_UP
      notificationId
      606539
    4. Role
      NOTIFYING
      notificationId
      634502
    5. Role
      FOR_FOLLOW_UP
      notificationId
      634502
    6. Role
      NOTIFYING
      notificationId
      634502
    7. Role
      OPERATOR
      notificationId
      634502
    Organisation
    code
    FR
    countryNetworkOrganizationId
    5013
    Description
    France
    Notification ID
    14
  2. Roles
    1. Role
      FOR_ATTENTION
      notificationId
      606539
    2. Role
      FOR_ATTENTION
      notificationId
      623029
    Organisation
    code
    INFO
    countryNetworkOrganizationId
    5680
    Description
    INFOSAN
    Notification ID
    10340
  3. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      634502
    2. Role
      FOR_ATTENTION
      notificationId
      683558
    3. Role
      FOR_ATTENTION
      notificationId
      623029
    4. Role
      FOR_ATTENTION
      notificationId
      668762
    5. Role
      ORIGIN
      notificationId
      606539
    6. Role
      ORIGIN
      notificationId
      634502
    7. Role
      OPERATOR
      notificationId
      668762
    8. Role
      OPERATOR
      notificationId
      634502
    Organisation
    code
    TR
    countryNetworkOrganizationId
    5223
    Description
    Türkiye
    Notification ID
    10218
  4. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      634502
    2. Role
      FOR_ATTENTION
      notificationId
      668762
    3. Role
      OPERATOR
      notificationId
      634502
    Organisation
    code
    US
    countryNetworkOrganizationId
    5230
    Description
    United States
    Notification ID
    10225

RASFF

Follow-ups

  1. fupDate
    20-04-2023 12:01:29
    fupId
    607480
    fupNumber
    1
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    14
    organizationCode
    FR
    organizationDescription
    France
  2. fupDate
    20-04-2023 15:35:49
    fupId
    607577
    fupNumber
    2
    fupType
    Description
    corrigendum
    Notification ID
    27663
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  3. fupDate
    25-04-2023 10:28:37
    fupId
    608127
    fupNumber
    3
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    14
    organizationCode
    FR
    organizationDescription
    France
  4. fupDate
    28-04-2023 16:19:17
    fupId
    608936
    fupNumber
    4
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  5. fupDate
    09-05-2023 17:35:06
    fupId
    610419
    fupNumber
    5
    fupType
    Description
    request
    Notification ID
    27665
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  6. fupDate
    26-05-2023 13:20:08
    fupId
    613424
    fupNumber
    6
    fupType
    Description
    follow-up from non-member country
    Notification ID
    27671
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  7. fupDate
    31-05-2023 09:49:50
    fupId
    614000
    fupNumber
    7
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    14
    organizationCode
    FR
    organizationDescription
    France
  8. fupDate
    13-07-2023 16:33:01
    fupId
    623029
    fupNumber
    8
    fupType
    Description
    follow-up from non-member country
    Notification ID
    27671
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  9. fupDate
    22-09-2023 15:28:43
    fupId
    634502
    fupNumber
    9
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    3
    organizationCode
    DE
    organizationDescription
    Germany
  10. fupDate
    25-09-2023 09:56:03
    fupId
    634519
    fupNumber
    10
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    14
    organizationCode
    FR
    organizationDescription
    France
  11. fupDate
    07-03-2024 12:11:19
    fupId
    668762
    fupNumber
    11
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    3
    organizationCode
    DE
    organizationDescription
    Germany
  12. fupDate
    08-05-2024 15:09:25
    fupId
    683558
    fupNumber
    12
    fupType
    Description
    follow-up from non-member country
    Notification ID
    27671
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission

RASFF

5013
  1. countryNetworkOrganizationId
    5013
    Notification ID
    14
  2. countryNetworkOrganizationId
    5013
    Notification ID
    15
    link
    http://www.economie.gouv.fr/dgccrf/Securite/Alertes/Avis-rappels-de-produits

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.