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 [email protected]
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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.