Publication #8228

Reference
Drug alert 34/2024
Name
Drug Alert Class 4 Drug Alert 34 2024 – Class 4 medicines defect information – caution in use – Sandoz Ltd – Omeprazole 10mg gastro-resistant capsules
Categories
Scottish Government Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS Scotland Drugs Safety Risks Pharmaceutical Industry Medicines Recall
Description
Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPCs) of the specific products listed in this notification. The product information does not include a warning/precaution for severe cutaneous adverse reactions (SCAR) in section 4.4, and adverse events of drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) in section 4.8 of the SmPC. 

Contact Name
Irene Fazakerley
Contact Address
Contact Phone

Created
2024-08-08 08:44:26


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