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UK Drug Safety Update · UK · 14 Sep 2025 · Safety alert & recall

Letters and medicine recalls sent to healthcare professionals in April 2024

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On 4 April 2024, the MHRA issued a National Patient Safety Alert about transfusion-associated circulatory overload (TACO), one of the most common causes of transfusion-related deaths in the UK, to highlight the need to reduce risks by identifying risk factors prior to transfusion. In April 2024, the MHRA issued four Class 3 medicines recalls affecting OPDIVO nivolumab, Co-Codamol effervescent tablets, Invokana tablets in Northern Ireland, and Suprefact solution for injection due to product quality issues or incorrect packaging. Two device safety alerts were also issued: a recall of Legency Remedies saline products due to potential microbiological contamination, and a voluntary suspension and recall of Symbios ORIGIN patient-matched knee replacement devices due to significantly higher revis

From UK Drug Safety Update

National Patient Safety Alert: Reducing risks for transfusion-associated circulatory overload (NatPSA/2024/004/MHRA)

On 4 April, we issued a National Patient Safety Alert to highlight the need to reduce risks for transfusion associated circulatory overload (TACO).

TACO is one of the most common causes of transfusion-related deaths in the UK and cases have increased substantially in recent years. Identifying risk factors for TACO prior to transfusion allows initiation of appropriate mitigating measures.

Letters

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

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

Class 3 Medicines Recall: Bristol-Myers Squibb Pharmaceuticals Limited, OPDIVO 10 mg/mL concentrate for solution for infusion (nivolumab), EL(24)A/11. Issued 4 April 2024. Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML). Healthcare professionals are advised to stop using the above batches immediately.

Class 3 Medicines Recall: Accord-UK Ltd, Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery), EL (24)A/12. Issued 10 April 2024. Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery) as a precautionary measure due to the internal tablet blister strips being printed with an incorrect expiry date. Only packs from the specified batch are affected. Healthcare professionals are advised to stop supplying the above batch immediately.

Class 3 Medicines Recall: A. Menarini Farmaceutica Internazionale Srl, Invokana 300mg tablets (Northern Ireland only), EL(24)A/13. Issued on 16 April 2024. A. Menarini Farmaceutica Internazionale Srl is recalling the above batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market. This affects Invokana 300mg (30 tablets) in Northern Ireland only. Healthcare professionals are advised to stop supplying the above batch immediately.

Class 3 Medicines Recall: Neon Healthcare Ltd, Suprefact 1 mg/ml solution for injection (Cheplapharm – Canadian Livery), EL(24)A/14. Issued 23 April 2024. Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure. This is because the named batch of Suprefact 1mg/ml solution for injection is being distributed in packaging intended for the Canadian market by Cheplapharm, instead of the correct UK packaging. Stop supplying the above batch immediately. Wholesalers are also requested to check stock of Buserelin 1 mg/ml solution for injection for any packs that match Suprefact 1 mg/ml solution for injection (MAH: Cheplapharm – Canadian Livery) as per the product images in the alert.

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