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.

The post MHRA Class 4 Medicines Defect Information: Concerta® XL 18mg & 36 mg prolonged release tablets (Orifarm UK Ltd) appeared first on Community Pharmacy England.