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
