europeanpharmaceuticalreviewMarch 11, 2020
Class 2 medicines recall
A Class 2 medicines recall of gliclazide 40mg tablets (Northstar Livery) PL 20075/0687 has been issed due to out of specification results for dissolution, obtained during routine stability testing for batch number GU50.
Accord-UK, which produces the drug, is recalling all unexpired stock of these gliclazide tablets from pharmacies and wholesalers as a precautionary measure.
The regulatory body has advised healthcare professionals to stop supplying the drugs from the batch immediately. All remaining stock should be quarantined and returned to the supplier.
Class 3 FMD medicines recall
A Class 3 recall has been announced for beconase aqueous nasal spray (Beclometasone Dipropionate 50μg) PL 10949/0104.
Glaxo Wellcome UK Ltd GSK, the drug makers, informed the MHRA of an issue related to error in the decommissioning of the K84X batch. Upon decommissioning at the pharmacy and when scanning the serialised two-dimensional (2D) code, the status of packs may report as ‘DESTROYED.’ Although there is no risk to product quality, any remaining stock should be quarantined and returned, says the agancy.
Healthcare professionals have been asked to halt supply of the batch with immediate effect and quarantine any remaining stock, for return to the supplier.
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