Class 4

Class 4 Medicines Defect Information: Orifarm UK Ltd, Concerta XL 18mg & 36 mg prolonged release tablets, EL (24)A/07

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Class 4 Medicines Defect Information: Orifarm UK Ltd, Concerta XL 18mg & 36 mg prolonged release tablets, EL (24)A/07

Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the specific batches of Concerta XL 18mg and 36mg prolonged release tablets mentioned in this notification.

MDR Number: MDR 060-02/24

Company name: Orifarm UK Ltd

Product description:

 Concerta XL 18mg prolonged release tablets, PLPI 46927/0226 & 46927/0227

Batch NoExpiry DatePack SizeFirst Distributed
3EE3580131/01/202630 tablets03/11/2023
3EE3580231/12/202530 tablets03/11/2023
3EE3610131/01/202630 tablets09/11/2023
3EE3580331/12/202530 tablets06/12/2023
3EE3610231/01/202630 tablets14/12/2023
3FE4610028/02/202630 tablets02/01/2024
3FE4610128/02/202630 tablets08/01/2024
3GE5190028/02/202630 tablets24/01/2024

 

Concerta XL 36mg prolonged release tablets, PLPI 46927/0062 & 46927/0207

Batch NoExpiry DatePack SizeFirst Distributed
3AE0710228/02/202630 tablets06/11/2023
3DE2950028/02/202630 tablets09/11/2023
3FE4410130/09/202530 tablets23/11/2023
3FE4410231/01/202630 tablets23/11/2023
3AE0710331/12/202530 tablets07/12/2023
3DE2920130/09/202530 tablets14/12/2023
3DE2950131/01/202630 tablets14/12/2023
3FE4410328/02/202630 tablets18/12/2023
3FE4680031/03/202630 tablets11/01/2024
3FE4680131/03/202630 tablets17/01/2024
3EE3700231/01/202630 tablets17/01/2024

 

Concerta XL 36mg prolonged release tablets, PLPI 46927/0063

Batch numberExpiry datePack sizeFirst distributed
3GE5000228/02/202630 tablets17/01/2024

Brief description of problem:

Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the above batches of Concerta XL 18mg and 36mg prolonged release tablets. A section of the product side effects containing the serious side effects has been added to paragraph 3 in error however this should be part of paragraph 4. All other sections of the PIL are unaffected.

Advice to Healthcare Professionals:

Healthcare professionals are advised to inform patients of this discrepancy when dispensing packs from the specified batches.

Advice to Patients:

Patients do not need to take any action. This issue is about an error in the patient information leaflet that accompanies the above specified batches of Concerta XL18mg and 36mg prolonged release tablets. Some information on the side effects is incorrectly included in paragraph 3 instead of paragraph 4. The quality of the medicine is not affected.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For medical information and stock control queries please email jacook@Orifarm.com, or telephone 01923 204333.

To access the full recall: Class 4 Medicines Defect Information: Orifarm UK Ltd, Concerta XL 18mg & 36 mg prolonged release tablets, EL (24)A/07