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

Published On:

15 October 2020

Published In:

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.

For full details including document download and who to contact for stock control enquires and medical information enquires please click here

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