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

Source: MHRA/Gov.uk 26.2.24

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 name

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

Batch No Expiry Date Pack Size First Distributed
3EE35801 31/01/2026 30 tablets 03/11/2023
3EE35802 31/12/2025 30 tablets 03/11/2023
3EE36101 31/01/2026 30 tablets 09/11/2023
3EE35803 31/12/2025 30 tablets 06/12/2023
3EE36102 31/01/2026 30 tablets 14/12/2023
3FE46100 28/02/2026 30 tablets 02/01/2024
3FE46101 28/02/2026 30 tablets 08/01/2024
3GE51900 28/02/2026 30 tablets 24/01/2024

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

Batch No Expiry Date Pack Size First Distributed
3AE07102 28/02/2026 30 tablets 06/11/2023
3DE29500 28/02/2026 30 tablets 09/11/2023
3FE44101 30/09/2025 30 tablets 23/11/2023
3FE44102 31/01/2026 30 tablets 23/11/2023
3AE07103 31/12/2025 30 tablets 07/12/2023
3DE29201 30/09/2025 30 tablets 14/12/2023
3DE29501 31/01/2026 30 tablets 14/12/2023
3FE44103 28/02/2026 30 tablets 18/12/2023
3FE46800 31/03/2026 30 tablets 11/01/2024
3FE46801 31/03/2026 30 tablets 17/01/2024
3EE37002 31/01/2026 30 tablets 17/01/2024

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

Batch number Expiry date Pack size First distributed
3GE50002 28/02/2026 30 tablets 17/01/2024

Active Pharmaceutical Ingredient: Methylphenidate Hydrochloride

Brief description of the 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 for healthcare professionals

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

Advice for 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.

Further Information

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

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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

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