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 and Neurology
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  Nutrition and dietetics, Obstetrics, gynaecology and fertility, Paediatrics and neonatology, Psychiatry, and 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