Class 4 Medicines Defect Information: Loprazolam 1mg tablets (Orifarm UK Ltd)

Class 4 Medicines Defect Information: Loprazolam 1mg tablets (Orifarm UK Ltd)

Drug alert number: EL (22)A/25

Date issued: 26th May 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Class 4 Medicines Defect Information: Loprazolam 1mg tablets (Orifarm UK Ltd)

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 below 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.

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

Active Pharmaceutical Ingredient: Loprazolam mesylate

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

View full alert here

Further Information

For medical information and stock control queries please contact: Gowthami Gandhamala at GOGAN@Orifarm.com

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