Class 4 Medicines Defect Information: Orifarm UK Ltd, Loprazolam 1mg Tablets, EL (22)A/25
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.
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.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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