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Publication #8421
Reference
Drug Alert 15/2025
Name
Drug Alert Class 4 Drug Alert 15 2025 – Class 4 medicines defect information – caution in use – RenaCare Nephromed GmbH – Renacet 475mg and 950mg tablets calcium acetate
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS
Scotland
Drugs
Safety
Risks
Pharmaceutical Industry
Caution in Use
Description
RenaCare NephroMed GmbH has informed the MHRA of the presence of an undeclared excipient in the coating of the tablets. This excipient is Macrogol 6000 which is included in Renacet tablets. Macrogol 6000 has always been included in Renacet Tablets but has been omitted from the list of excipients in error.
The batches listed as ‘not yet distributed’ have also been manufactured and packed with macrogol 6000. The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients, therefore these batches will not be repackaged and continue to be distributed. They are therefore included in the notification.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2025-04-07 08:24:00
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