MHRA Class 4 Medicines Defect Information: Concerta® XL 18mg & 36 mg prolonged release tablets (Orifarm UK Ltd)
Class 4 Medicines Defect Information: Concerta® XL 18mg & 36 mg prolonged release tablets (Orifarm UK Ltd)
Drug alert number: EL (24)A/07
Date issued: 26 February 2024
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Concerta® XL 18mg & 36 mg prolonged release tablets (Orifarm UK Ltd)
Company name: Orifarm UK Ltd
Product name: Concerta® XL 18mg prolonged release tablets, PLPI 46927/0226 & 46927/0227
| Batch Number | 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 |
Product name: Concerta® XL 36mg prolonged release tablets, PLPI 46927/0062 & 46927/0207
| Batch Number | 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 |
Product name: 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.
View full alert here.
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.
