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
