Letters and medicine recalls sent to healthcare professionals in March 2024

A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 29 April 2024

• Therapeutic area: Cancer, Ear, nose and throat, Endocrinology, diabetology and metabolism, GI, hepatology and pancreatic disorders, Neurology, Nutrition and dietetics, Obstetrics, gynaecology and fertility, Paediatrics and neonatology, Psychiatry, Urology and nephrology

Letters

In March 2024, the following letters were sent or provided to relevant healthcare professionals:

• Fiasp® FlexTouch® (fast-acting insulin aspart) 100 units/ml solution for injection 3ml pre-filled pen: Supply Shortage in the UK
• Oestrogel (estradiol) Pump-Pack 750 micrograms/actuation Gel Recall VERORAB, powder and solvent for suspension for injection - PLGB 46602/0029
• Diazepam Desitin 10mg Rectal Solution BSV
• GAVRETO®▼(pralsetinib): Planned transition of Market Authorisation Holder for GAVRETO®▼(pralsetinib) from Roche Products Ltd to BluePrint Medicines resulting in discontinuation of supply from Roche Products Ltd
• Tresiba® FlexTouch® 100 U/mL solution for injection (insulin degludec): Supply Shortage in the UK and Tresiba® FlexTouch® 200 U/mL solution for injection (insulin degludec): Medication error
• Norditropin NordiFlex® (somatropin): Product Discontinuation Norditropin® FlexPro® 5mg/1.5ml (somatropin): Drug Shortage and Pause in production

Medicine Recalls and Notifications

In March 2024, recalls and notifications for medicines were issued on:

Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml, solution for injection/infusion (folinic acid 400mg/8ml vial), EL(24)A/08. Issued: 12 March 2024. medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified in this notification due to particles detected during long-term stability tests.

Class 3 Medicines Recall: Besins Healthcare (UK) Ltd, Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol), EL (24)A/09. Issued: 19 March 2024. Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.

Class 4 Medicines Notification: Fresenius Kabi Limited, Sodium Chloride Intravenous Infusion 0.9% Freeflex, EL (24)A/10. Issued: 21 March 2024. Fresenius Kabi Limited has informed the MHRA of an error on the infusion bag packaged into the specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex.

Medical Device Safety Information

We recently published Device Safety Information pages on the following topics:

Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly or worsen choking incidents if used, (DSI/2024/003). Issued: 25 March 2024. Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed. There are numerous counterfeit and unbranded anti-choking devices being sold in the UK online which do not have a valid UKCA or CE mark and may pose a significant risk of worsening choking if used. These devices should not be used in the event of a choking emergency and should be disposed of once identified as counterfeit or non-compliant. For additional information, please refer to the Device Safety Information page.

Article citation: Drug Safety Update volume 17, issue 9: April 2024: 3

Published 29 April 2024