Class 2 Medicines Recall: Sanofi Epilim 500mg Gastro-Resistant Tablets EL (20)A/48*

Sanofi is recalling batches of product as a precautionary measure due to out of specification results for disintegration test during routine stability testing.

MDR Number

MDR 159-08/20

Company Name

Sanofi

PL number

PL 04425/0303

Product description

Epilim 500mg Gastro-Resistant Tablets

Batch number Expiry date Pack size First distributed
R0601 08/2022 30 6 November 2019
R0602 08/2022 30 5 November 2019
R0603 08/2022 30 6 November 2019

Active Pharmaceutical Ingredient: sodium valproate

Brief description of the problem

Sanofi is recalling the above batches of product as a precautionary measure due to out of specification results for disintegration test during routine stability testing.

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

Further Information

For stock control enquiries please contact GB-CustomerServices@sanofi.com or phone 0800 854 430

For medical information enquiries please contact uk-medicalinformation@sanofi.com or call 0800 035 25 25

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 community pharmacists and dispensing general practitioners for information.

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Class 2 Medicines Recall: Epilim 500mg Gastro-Resistant Tablets, EL (20)A/48*

Updates to this page

Published 14 October 2020