Roche voluntary admission: Gazyvaro nurse leavepiece contained a 10x dosing typo (AUTH/3568/10/21)

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Key facts

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Case	AUTH/3568/10/21
Company	Roche
Product	Gazyvaro (obinutuzumab)
Material	Promotional leavepiece / ring bound booklet approx A6; ref M-GB-00000509
Error	Page 6 chart for CLL infusion rates: Cycle 1 Day 1 dose shown as 1000mg instead of 100mg
Certified/approved	22 July 2020
Error identified	1 September 2021
HCP notification sent	6 October 2021 (post to 234 haematology units)
Distribution	550 hard copies distributed; 16 downloads from Roche HCP resource website
Applicable Code year	2021
Complaint received	06 October 2021
Case completed	07 December 2021
Breach clauses	2, 5.1, 6.1
Sanctions	Undertaking received; Additional sanctions: Advertisement
Appeal	No appeal

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

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Roche made a voluntary admission about a certified promotional leavepiece for Gazyvaro (obinutuzumab) (ref M-GB-00000509), described as intended for haematology specialist nurses.
A chart on page 6 (infusion rates for CLL patients) listed the Cycle 1 Day 1 Gazyvaro dose as 1000mg instead of 100mg (a typographical error).
The leavepiece was certified and approved on 22 July 2020.
The error was identified by an employee on 1 September 2021 during printing of a new batch.
Distribution/exposure: 550 hard copies distributed by representatives; 16 downloads from Roche’s health professional resource website.
Roche withdrew the leavepiece, initiated an investigation (including safety database review), and later wrote to relevant units asking for destruction of the material.
Health professionals were notified by post on 6 October 2021 (letter sent to 234 UK haematology units with potential to administer Gazyvaro).

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Breach of Clause 6.1 (information inaccurate and misleading) – ruled by the Panel (and acknowledged by Roche).
Breach of Clause 5.1 (high standards not maintained) – ruled by the Panel (and acknowledged by Roche).
Breach of Clause 2 – ruled by the Panel because the dosing error might have prejudiced patient safety (Clause 2 is reserved for particular censure).
No appeal.

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