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RASFFReference 2020.5323

Presence of pharmacologically active substance Pancreatin in food supplement, DIGESTON 60 caps

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

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RASFF

Identification and classification

Reference
2020.5323
Notification ID
452488
Classification
alert notification
Risk decision
serious
Product type
food
Notification basis
official control on the market
Status
ec_validated

RASFF

Product

Description
FOOD SUPPLEMENT, "DIGESTON"
Distribution status
Description
product traded online
Notification ID
228
Notification ID
3273975
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    3275753
    productAspect
    60 tablets/unit
    temperature
    Description
    ambient
    Notification ID
    27368

RASFF

Risk and analytical results

hazardObserved
According to the Spanish Agency for Medicines and Health Products's Opinion, it is confirmed that this supplement -containing pancreatin, pharmacologically active substance- is considered an illegal medicinal product,
Notification ID
42072

RASFF

Measures

  1. Action taken
    Description
    monitoring of the recall/withdrawal
    Notification ID
    18846
    Notification ID
    3276144
    takenBy
    Notification ID
    5010
    isoCode
    ES
    organizationName
    Spain

RASFF

Origin, notification and distribution

Origin
United Kingdom
Notifying country or territory
Spain
Published distribution
Andorra, Spain
Affected territories
Andorra · Spain

RASFF

Published territorial roles

  1. Roles
    1. Role
      DISTRIBUTION
      notificationId
      462852
    2. Role
      DISTRIBUTION
      notificationId
      456544
    Organisation
    code
    AD
    countryNetworkOrganizationId
    5039
    Description
    Andorra
    Notification ID
    10034
  2. Roles
    1. Role
      NOTIFYING
      notificationId
      452488
    2. Role
      NOTIFYING
      notificationId
      452488
    3. Role
      DISTRIBUTION
      notificationId
      452488
    4. Role
      NOTIFYING
      notificationId
      462852
    5. Role
      DISTRIBUTION
      notificationId
      462852
    6. Role
      NOTIFYING
      notificationId
      462852
    7. Role
      OPERATOR
      notificationId
      462852
    8. Role
      NOTIFYING
      notificationId
      452488
    9. Role
      OPERATOR
      notificationId
      452488
    Organisation
    code
    ES
    countryNetworkOrganizationId
    5010
    Description
    Spain
    Notification ID
    2
  3. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      452488
    2. Role
      ORIGIN
      notificationId
      452488
    3. Role
      OPERATOR
      notificationId
      452488
    Organisation
    code
    GB
    countryNetworkOrganizationId
    5014
    Description
    United Kingdom
    Notification ID
    17

RASFF

Follow-ups

  1. fupDate
    26-11-2020 11:34:16
    fupId
    452538
    fupNumber
    1
    fupType
    Description
    translation
    Notification ID
    27675
    networkOrganizationId
    2
    organizationCode
    ES
    organizationDescription
    Spain
  2. fupDate
    16-12-2020 13:11:14
    fupId
    456544
    fupNumber
    2
    fupType
    Description
    outcome of investigations and measures taken
    Notification ID
    27659
    networkOrganizationId
    2
    organizationCode
    ES
    organizationDescription
    Spain
  3. fupDate
    22-12-2020 10:46:54
    fupId
    457592
    fupNumber
    3
    fupType
    Description
    outcome of investigations
    Notification ID
    27674
    networkOrganizationId
    17
    organizationCode
    GB
    organizationDescription
    United Kingdom
  4. fupDate
    27-01-2021 16:05:28
    fupId
    462852
    fupNumber
    4
    fupType
    Description
    outcome of investigations and measures taken
    Notification ID
    27659
    networkOrganizationId
    2
    organizationCode
    ES
    organizationDescription
    Spain

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.