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UK Drug Safety Update · UK · 6 Nov 2024 · Safety alert & recall

Letters and medicine recalls sent to healthcare professionals in October 2024

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In October 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued three Class 2 recalls, one Class 3 recall, and four Class 4 defect notifications for medicines. Recalls included Phenobarbital tablets due to potential metallic particle contamination, Labetalol tablets due to potential product mix-up, Trandolapril capsules due to content variability, and Cyanocobalamin tablets due to unknown impurities. Defect notifications concerned missing safety information in Rosuvastatin and Linezolid documentation and incorrect sodium content labeling in Paracetamol effervescent tablets.

From UK Drug Safety Update

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

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

Class 2 Medicines Recall: Bristol Laboratories Ltd, Phenobarbital Bristol Labs 15mg Tablets, EL(24)A/50. Issued 23 October 2024. Bristol Laboratories Ltd. are recalling one batch of Phenobarbital Bristol Labs 15mg Tablets as a precautionary measure due to the potential of contamination of small metallic particles within the tablets.

Class 2 Medicines Recall: Tillomed Laboratories Limited, Labetalol 200mg Tablets, EL(24)A/52. Issued 29 October 2024. Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site. A limited number of Labetalol 200mg Tablets (Batch Number 240537) cartons may contain a blister strip of Vera-Til SR 240mg Tablets, (verapamil), PL 11311/0078 (Batch Number 240750) with the blister strips of Labetalol 200mg Tablets.

Updated 31 October 2024. This recall notification has been updated to include the correct description for Labetalol 200mg Tablets. Tillomed Laboratories Limited erroneously provided incorrect information pertaining the description and have ensured that all other information is correct.

Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets, EL(24)A/46. Issued 3 October 2024. Glenmark Pharmaceuticals Europe Ltd is recalling the affected batches as a precautionary measure due to out of specification results for unknown impurities during routine stability testing and additional re-testing.

Updated 24 October 2024. This recall notification has been updated to include the correct batch information for Cyanocobalamin 50 mcg Tablets, batch 17231510A. Glenmark Pharmaceuticals Europe Ltd erroneously provided incorrect information pertaining the expiry date of batch 17231510A and have ensured that all other batch information is correct.

Class 3 Medicines Recall: Viatris UK Healthcare Ltd, Trandolapril 2mg and 4mg capsules, EL(24)A/47. Issued 7 October 2024. Generics (UK) Ltd T/A Mylan UK is recalling specific batches of trandolapril after re-testing showed out of specification results. The listed batches in this notification are being recalled as a precautionary measure after testing showed variability of the Trandolapril content.

Class 4 Medicines Defect Information: Sandoz Ltd., Rosuvastatin 20mg, 40mg Tablets, EL(24)A/45. Issued 1 October 2024. Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Rosuvastatin 20mg and 40mg Tablets.

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