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Director Letters (formerly MELs/CELs/HDLs etc) are currently being reviewed to ensure it is clear which publications are current, superseded or obsolete.
Publication #8492
Reference
Drug Alert 32/2025
Name
Drug Alert class 4 – No 32 2025 – Class 4 medicines defect information – caution in use – Amdipharm UK Ltd – Erthromycin Stearate BP 250mg tablets
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS
Scotland
Drugs
Risk
Safety
Pharmaceutical Industry
Description
Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL. The superseded PIL used in Batch 6104532 is missing important updated safety information, as per the recommendation from Pharmacovigilance Risk Assessment Committee (PRAC).
Amdipharm UK Ltd has confirmed that 4515 packs of the affected batch are already distributed in the market and 6823 packs are awaiting distribution. Due to supply considerations the remaining packs (6823 units) will continue to be distributed.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2025-07-01 12:07:09
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