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

MDR Number: 077-05/22

Company name: Orifarm UK Ltd

Product description: Loprazolam 1mg Tablets – PLPI 46927/0262

Details of the affected batch:

Brief description of 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 to 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 to 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

Company contacts for further information:

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

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

To access the full recall:

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