Ferring Pharmaceuticals: failure to fully withdraw Pentasa leavepiece with incorrect prescribing information (AUTH/3716/11/22)

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Key facts

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Case	AUTH/3716/11/22
Complainant	Tillotts Pharma UK Ltd
Respondent	Ferring Pharmaceuticals Ltd
Material	Pentasa adult summary leavepiece (ref UK-PA-2100024)
Main issue	Failure to fully withdraw a leavepiece containing incorrect prescribing information; continued accessibility via a remaining hyperlink
Incorrect vs SPC wording (as described)	Material stated division “2–4” doses; SPC stated “two or three” divided doses (once daily also referenced in both)
Timeframe highlighted	~11 weeks after confirming withdrawal during inter-company dialogue
Applicable Code	2021
Breach clauses	Clause 5.1
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	23 November 2022
Case completed	24 January 2024
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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Tillotts and Ferring entered inter-company dialogue about Pentasa promotional material containing incorrect prescribing information for adult acute dosing (division of doses stated as “2–4” rather than “two or three”).
Ferring confirmed in a letter dated 2 September 2022 that “materials which include this Prescribing Information have been withdrawn”.
Tillotts later found the Pentasa adult summary leavepiece (UK-PA-2100024) still accessible on the Ferring UK Hub via a “view booklet” link.
The material remained accessible for around 11 weeks after Ferring’s confirmation of withdrawal.
Ferring said it removed the main hyperlinks but missed another (hidden) hyperlink due to website architecture complexity; it accepted responsibility for the error and the incomplete withdrawal.

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Breach ruled: Clause 5.1 (2021 Code) for failing to maintain high standards due to inadequate control and failure to fully withdraw the material.
No appeal.

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