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4 May 2021 by Jacquie Lee

Class 4 Medicines Defect Information, Syonell 250mg Gastro-Resistant Tablets,(PL 35507/0191), Syonell 500mg Gastro-Resistant Tablets, (PL 35507/0192),

  • Wales
  • England
  • Scotland
  • Northern Ireland

Lupin Healthcare (UK) Limited has informed us of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets. This discrepancy relates to the incorrect amount of active pharmaceutical ingredient (valproate semisodium) printed on the outer packaging.

MDR Number MDR 012-04/21

Company name Lupin Healthcare (UK)

Product description

Syonell 250mg Gastro-Resistant Tablets

Details of affected batches

Batch number

Expiry date

Pack size

First distributed

G908002

Sep-21

30

06/01/2020

G908614

Oct-21

30

08/04/2020

G908561

Oct-21

30

20/03/2020

G003139

Mar-22

30

18/06/2020

G003899

Apr-22

30

25/09/2020

G003900

Apr-22

30

05/10/2020

G003901

Apr-22

30

04/02/2021

The following batches have been packed and are awaiting distribution:

Batch number

Expiry date

Pack size

First distributed

G004456

May-22

30

-

G004457

May-22

30

-

Syonell 500mg Gastro-Resistant Tablets

Details of affected batches

Batch number

Expiry date

Pack size

First distributed

G908022

Sep-21

30

27/12/2019

G908441

Oct-21

30

09/03/2020

G908835

Oct-21

30

15/03/2020

G000647

Dec-21

30

20/03/2020

G000648

Dec-21

30

05/04/2020

G002361

Feb-22

30

11/05/2020

G002362

Feb-22

30

12/05/2020

G002363

Dec-21

30

28/05/2020

G002901

Mar-22

30

18/06/2020

G004160

Apr-22

30

24/09/2020

G004161

Apr-22

30

27/09/2020

G004168

Apr-22

30

26/10/2020

G004169

Apr-22

30

08/12/2020

G004170

Apr-22

30

01/02/2021

G004171

Apr-22

30

09/03/2021

G004931

May-22

30

11/01/2021

The following batches have been packed and are awaiting distribution:

Batch number

Expiry date

Pack size

First distributed

G004936

May-22

30

-

G004938

May-22

30

-

G004940

May-22

30

-

G004941

May-22

30

-

G004932

May-22

30

-

G004933

May-22

30

-

Brief description of problem

Lupin Healthcare (UK) Limited has informed us of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets. This discrepancy relates to the incorrect amount of active pharmaceutical ingredient (valproate semisodium) printed on the outer packaging.

Labelling on the current packaging

Correct labelling on the packaging

Syonell 250mg Gastro-Resistant Tablets. Each gastro-resistant tablet contains 250mg of valproate semi sodium

Syonell 250mg Gastro-Resistant Tablets. Each gastro-resistant tablet contains 269.06mg of valproate semisodium equivalent to 250mg of valproic acid

Syonell 500mg Gastro-Resistant Tablets. Each gastro-resistant tablet contains 500mg of valproate semi sodium

Syonell 500mg Gastro-Resistant Tablets. Each gastro-resistant tablet contains 538.12mg of valproate semisodium equivalent to 500mg of valproic acid

The amounts of active pharmaceutical ingredient are stated correctly in the respective Patient Information Leaflets (PIL) and Summary of Product Characteristics (SmPCs).

Advice to Healthcare Professionals

Healthcare professionals are advised to exercise caution when dispensing the product. There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled.

Company contacts for further information

For more information or medical information queries, please contact: +44 (0) 1565 751 378 Option 1 or Pharmacovigilance Department at EU-PV@lupin.com

For stock control queries, please contact: 44 (0) 1565 751 378 Option 2 or information@lupin.com

Full Recall

Drug alert class 4

Drug alert class 4

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