Publication #8552

Reference
Drug Alert 44/2025
Name
Drug Alert class 4 - No 44 2025 - Class 4 medicines defect information - caution in use - RelonChem LTD - Various products
Categories
Scottish Government Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS Scotland Drugs Safety Risks Pharmaceutical Industry
Description
Healthcare professionals are advised to use caution and consider extra safeguards for these batches in robotic or automated dispensing system or stocking systems and should carry out manual dispensing and stocking, as appropriate. Pharmacy providers should also consider local assessments, in line with this notification and inform Relonchem Ltd of any stock that cannot be used in an automated dispensing system.
Losartan potassium & Losartan potassium/hydrochlorothiazide tablets

The product quality of the Losartan Potassium 50mg and 100mg coated tablets and Losartan potassium/Hydrochlorothiazide 50mg/12.5mg and 100mg/25mg coated tablets are not impacted by this issue, therefore the affected batches are not being recalled.

RelonChem Ltd have advised that a further 132 units of Losartan potassium/Hydrochlorothiazide 50mg/12.5mg and 4780 units of Losartan potassium/Hydrochlorothiazide 100mg/25mg will be released to the market to meet customer orders and supply requests. Stock will be marketed until 30 Nov 2025 and all new batches marketed after this date will be packed with the new GTIN barcodes.

All remaining stock of Losartan Potassium 50mg and 100mg coated tablets will not be onward distributed and future batches of Losartan Potassium 50mg and 100mg coated tablets will be marketed with the new GTIN barcodes.
Risperidone 0.5mg Tablets (Almus livery)

The product quality of the Risperidone 0.5mg tablets in Almus livery is not impacted by this issue, therefore the affected batches are not being recalled.

RelonChem Ltd have confirmed that no further product will be distributed with the duplicated barcodes. All new batches produced by the manufacturing site and distributed, will be packed with new EAN barcodes.

Contact Name
IRENE FAZAKERLEY
Contact Address
St Andrew's House, Regent Road, Edinburgh
Contact Phone

Created
2025-10-23 12:46:00


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