Please note: Work is currently underway to update content available on this site.
Director Letters (formerly MELs/CELs/HDLs etc) are currently being reviewed to ensure it is clear which publications are current, superseded or obsolete.
Director Letters (formerly MELs/CELs/HDLs etc) are currently being reviewed to ensure it is clear which publications are current, superseded or obsolete.
Publication #8068
Reference
Drug alert 07/2024
Name
Drug alert class 4 – 07 2024 – Class 4 medicines defect information – caution in use – Orifarm UK Ltd, Concerta XL 18mg & 36mg prolonged release tablets
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS
Scotland
Drugs
Safety
Risks
Pharmaceutical Industry
Medicines Recall
Description
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.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2024-02-26 15:58:58
Click to go back to homepage