Class 4 Caution in Use: Arava 10mg film-coated tablets (Leflunomide)

Sanofi has informed us that there is an error in the Braille on some batches of Arava 10mg film-coated tablets (EL (17)A/01)

Product information

EL number

EL (17)A/01

MDR number

MDR 118-11/16

Company name

Sanofi-Aventis Deutschland GmbH

Product description

Arava 10mg film-coated tablets (Leflunomide) EU/1/99/118/003

Batch Number Expiry Date Pack Size First Distributed
5JK2A Nov 2018 1 x 30 16 May 2016
5JK3A Dec 2018 1 x 30 08 Aug 2016
5JK6G Jan 2019 1 x 30 12 Sep 2016
6EV2A May 2019 1 x 30 25 Oct 2016

Brief description of the problem

Sanofi on behalf of Sanofi-Aventis Deutschland GmbH, has informed us that there is an error in the Braille on 1 in 5 cartons from the above batches. On affected cartons, the strength of the product reads ‘20mg’ instead of ‘10mg’ in Braille. The printed text is correct on all packaging.

There is a risk to patients who have compromised eye-sight and who rely solely on Braille to determine their tablet strength. Packs with the above batch numbers should not be dispensed to patients who rely solely on Braille. We understand that there is an alternative batch available, batch number 6GL5E, expiry Aug 2019. If your wholesaler does not have this batch in stock, please contact Sanofi Customer Services on 0800 854 430.

Company details

For medical information enquiries, please contact Sanofi Medical Information department on 0845 3727101 or email

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Arava 10mg film-coated tablets - class 4 caution in use - EL (17)A/01

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to relevant clinics, dispensing GPs and community pharmacists for information.

Published 3 January 2017