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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