Reference

Drug alert 43/2023

Name

Drug alert class 4 – 43 2023 – Class 4 medicines defect information – caution in use – Atnahs Pharma UK Limited Clobazam Atnahs 5mg/5ml Oral Suspension

Categories

Scottish Government Drug Alerts

Organization

Scottish Government Health and Social Care Directorates

Keywords

NHS SCOTLAND DRUGS SAFETY RISKS PHARMACEUTICAL INDUSTRY MEDICINES RECALL

Description

Atnahs Pharma UK Ltd has informed the MHRA that the batches of Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension listed in this notification do not contain the most up to date safety information. The Summary of Product Characteristics (SmPC) and the Patient Information Leaflets (PIL) present in the pack are missing significant information. This is in relation to the use of the product in children (contraindicated), pregnancy, depression, drug dependence, numerous interactions and adverse effects, which are missing from the PIL present in the pack and in the SmPC. Please see below for an extract of the key information that was missing in the leaflets packed in the batches affected. Healthcare professionals and patients should note that the full details for information missing in the SmPC and in the PIL for these batches are listed in the appendices within this notification. Healthcare professionals should note that the information in the PIL and SmPC has already been updated and the relevant links can be found in the following sections of this notification.

Contact Name

Annie Gonelli

Contact Email

Contact Address

Pharmacy & Medicines Scottish Government 1R St Andrew’s House Regent Road Edinburgh EH1 3DG

Contact Phone

Created

2023-12-13 00:00:00

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