Recordati breached the Code over misleading guideline and “lowest volume” claims in Cleen/CitraFleet ad (AUTH/2875/9/16)

📊

Key facts

⌄

Case number	AUTH/2875/9/16
Complainant	Health professional
Company	Recordati Pharmaceuticals Ltd
Products	Cleen; CitraFleet
Material	Two-page journal advertisement (first page split between products; second page prescribing information)
Publication / date	Gastrointestinal Nursing, September 2016
Main issues	Exaggeration (“remarkable events”); misleading guideline impression; “lowest volume” superlative/unclear comparator; comparative claims without clear comparator; illegible prescribing information
Applicable Code year	2016
Complaint received	21 September 2016
Case completed	23 November 2016
Appeal	No appeal
No breach clauses	7.2, 7.3
Breach clauses	4.1, 7.2, 7.3, 7.10
Sanctions	Undertaking received; additional sanctions not stated

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

A health professional complained about a two-page print advertisement for Cleen and CitraFleet published in Gastrointestinal Nursing (September 2016).
The ad headline referred to “two remarkable events” (Cleen rebranding from Fleet to Cleen; and CitraFleet’s newly approved split-dose regimen).
The Cleen section included a “Quick Action” claim referenced to the SPC.
The CitraFleet section stated: “The Approval of the SPLIT DOSE REGIME in accordance to the European Guidelines” and “CitraFleet is the FIRST SPMC in Europe combining split dose regime according to the Guidelines, with the lowest volumen and an effective colon cleansing**”.
The ad also included claims such as “Effective bowel cleansing with low side effects and less impact on daily living” and “Preferred by patients for its low volumen, nice lemon flavour and the free choice of clear liquids”, without clearly stating the comparator.
The complainant said the prescribing information was hard to read due to long line length (>100 characters per line).

⚖️

⌄

Breach found for exaggeration: describing the developments as “remarkable events” was considered an overstatement.
No breach for Cleen “Quick Action”: the Panel accepted the SPC wording (2–5 minutes to effect) could be seen as quick and the complainant did not prove it was misleading or an unfair comparison.
Breach found for misleading guideline impression: the ad implied CitraFleet’s split-dose regimen was mentioned/supported by the ESGE guideline when CitraFleet was not mentioned.
Breach found for “lowest volume” superlative and unclear comparator: only one product can have the “lowest” volume; and the relevant volume should consider the whole regimen (reconstituted product plus required clear liquids). Comparator was unclear and the claim was misleading.
Breach found for comparative-style claims where the comparator (PEG) was not made clear, rendering the claims misleading.
Breach found for prescribing information legibility: line length and spacing meant it was not clear/legible.
No appeal.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access