Lundbeck Limited

Private and voluntary organisations · Private limited company

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First report 12 Mar 2024•Latest report 12 Mar 2024

Reports, concerns and published responses

Reports over time

Reports naming this recipient by issue year.

* 2026 is projected from reports observed to 7 Sep 2026.

Reports
1

Naming this recipient

Published responses
100%

Found for named reports

Concerns addressed
1

Across all linked responses

Stated actions
1

Described in responses

Concerns and recipient responses

Statements from Lundbeck Limited linked to the concerns in each report. Select any concern, action or position to view the source wording.

  1. Sunderland

    AI-generated summary

    Jason Brown · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Jason Brown died at his home on 6 September 2022 after taking an overdose of his prescribed medication; the inquest concluded suicide, with the medical cause recorded as cardiac arrhythmia and drug overdose. The report raises concern that original-pack dispensing requirements for Zuclopenthixol dihydrochloride could provide a patient with suicidal risk and previous overdose attempts with a large quantity of medication.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Lundbeck Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure to prevent full-pack dispensing of Zuclopenthixol to patients prescribed weekly doses with suicidal risk and previous overdose attempts

    Wider context from the report

    “At the Inquest I heard evidence that prior to his death on 6th September 2022, Jason Brown received from the pharmacy his prescribed medication in a form of a full pack of ████████ tablets of Zuclopenthixol dihydrochloride (clopixol). The pharmacy confirmed in evidence that this had been dispensed as a full pack in accordance with its special container status. Jason was prescribed his medication in weekly doses due to a history which included previous attempts to take an overdose of his medication. Jason received this full pack of tablets only 17 days before taking an overdose of this medication on 6th September 2022. The pharmacy also confirmed that another patient at the practice received the same medication in a 7-day monitored dosage system (MDS) but could not confirm whether the remaining pack was then disposed of for that patient. I am concerned that, due to a special container status, a box of ████████ tablets of Zuclopenthixol dihydrochloride (clopixol) must be dispensed in its own special container as a full pack of ████████ tablets (original pack dispensing) and that this can endanger the safety of a patient with a history of suicidal risk and previous overdose attempts. Deaths may be prevented if the original pack dispensing guidance was reviewed for this medication. ”
    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Provide stability data for Lundbeck zuclopenthixol tablets to support assessment of special container status.

    Verbatim wording from the response

    “• Following your current request, Lundbeck Ltd has queried the NHS Business Authority on 13 March 2024, regarding the criteria for assigning products as special containers and included that stability data are available supporting the storage of zuclopenthixol 2mg tablets being kept out of the container for up to 4 weeks if required.”

    Source location

    Response from Lundbeck Ltd
    Page 1 · response
    Published 19 March 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The NHS Business Services Authority independently assigns special container status under the applicable Drug Tariff criteria.

    Verbatim wording from the response

    “• The criteria for assigning products as special containers are listed within the NHS England and Wales Drug Tariff (Part II, Clause 10B)² and the NHS Business Service Authority (NHSBSA) implement the criteria.”

    Source location

    Response from Lundbeck Ltd
    Page 1 · response
    Published 19 March 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The manufacturer does not specify or classify the product as requiring special container status in its regulatory documents.

    Verbatim wording from the response

    “• Lundbeck Ltd does not specify, classify, or make any reference to zuclopenthixol 2mg tablets, nor any strength of Lundbeck branded zuclopenthixol tablets as requiring “special container status” within the Summary of Product Characteristics (SmPC) or any regulatory documents associated with this product. This classification is assigned and assigned independently².”

    Source location

    Response from Lundbeck Ltd
    Page 1 · response
    Published 19 March 2024

    Open published response
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026