Letters and medicine recalls sent to healthcare professionals in May 2024
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Letters
In May 2024, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In May 2024, recalls and notifications for medicines were issued on:
Class 4 Medicines Defect Information: Cygnus Pharma Ltd, Trazodone Hydrochloride 50mg/5ml Oral Solution, EL (24)A/16. Issued: 20 May 2024. Cygnus Pharma Ltd. have informed the MHRA that the European Article Number (EAN) barcode printed on various packs of Trazodone Hydrochloride 50mg/5ml Oral Solution is defective and returns the incorrect information.
Class 3 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets, EL(24)A/15. Issued: 22 May 2024. The MHRA has re-issued this notification as a Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the notification. Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on various parallel imported packs which have been repackaged by BModesto B.V.
Class 4 Medicines Defect Information: Fresenius Kabi Limited, Sodium Chloride 0.9% Intravenous Infusion BP (Freeflex and Freeflex Plus), EL (24)A/17.. Issued: 22 May 2024. Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS. Some batches were packaged without the patient information leaflet (PIL), and some were packaged with an older version of the PIL.
Article citation: Drug Safety Update volume 17, issue 11: June 2024: 3