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Class 4 Medicines Defect Information: Orifarm UK Ltd, Loprazolam 1mg Tablets, EL (22)A/25

Published On:

26 May 2022

Published In:

Orifarm UK have informed us of an error with the Patient Information Leaflet (PIL) packaged within the packs of certain batches. The product name stated in the heading of the PIL has been spelt incorrectly as “lorazolam”, instead of “loprazolam”. All other sections of the PIL are unaffected.

MDR Number

MDR 077-05/22

Company name

Orifarm UK Ltd

Product description

Loprazolam 1mg Tablets – PLPI 46927/0262

Batch Number Expiry Date Pack Size First Distributed
20001T00 31 Oct 2023 30 tablets Nov 2021
20001T01 31 Oct 2023 30 tablets Nov 2021

Active Pharmaceutical Ingredient: Loprazolam mesylate

Brief description of the problem

Orifarm UK have informed us of an error with the Patient Information Leaflet (PIL) packaged within the packs of the above batches. The product name stated in the heading of the PIL has been spelt incorrectly as “lorazolam”, instead of “loprazolam”. All other sections of the PIL are unaffected.

Advice for healthcare professionals

Healthcare professionals are advised to inform patients of this discrepancy when dispensing packs from this batch. Hard copies of the correct PIL could be provided by the Marketing Authorisation Holder upon request, so that any of the affected packs remaining in the dispensary can be supplemented with the correct PIL.

Advice for patients

There is a spelling error in the Patient Information Leaflet that accompanies these batches of loprazolam. The medicine itself is not affected and patients do not need to take any action.

 

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