GovWire

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Letters

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

• Medroxyprogesterone acetate: Risk of meningioma and measures to minimise this risk
• Idacio ? 40 mg solution for injection in pre-filled pen (adalimumab) & Idacio 40 mg solution for injection in pre-filled syringe (adalimumab) - PLGB 08828/0321 and 0322: Temporary Supply of Swedish/Finnish labelled stock
• Glatiramer acetate: Anaphylactic reactions may occur months to years after treatment initiation
• Infanrix hexa [diphtheria, tetanus, pertussis (acellular), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b]: Packaging issue potentially impacting the sterility of needle softpacks of 2 batches of Infanrix hexa for Northern Ireland (batch A21CE437A and A21CE376A).
• PyzchivaTM? (ustekinumab) 90 mg solution for injection in pre-filled syringe Interim Supply of Nordics Stock (Homecare company)
• PyzchivaTM? (ustekinumab) 130 mg concentrate for solution for infusion Interim Supply of Nordics Stock (Wholesaler)
• Fampyra 10mg Prolonged Release Tablets (fampiridine): Interim Supply of Belgium Stock to Mitigate Supply Disruption

Medicine Recalls and Notifications

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.

Class 4 Medicines Defect Information: Sandoz Ltd., Linezolid 600 mg film-coated tablets, EL(24)A/48. Issued 10 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 Linezolid 600 mg film-coated tablets.

Class 4 Medicines Defect Information: Kent Pharma UK, Paracetamol 500mg Effervescent Tablets, EL(24)A/49. Issued 21 October 2024. Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets. The PIL incorrectly states that the maximum daily dose contains 438mg of sodium, whereas this is the sodium content for a single dose. The maximum daily dose is in fact 3504mg of sodium.

Class 4 Medicines Defect Information: Kent Pharma UK, Parasolve (Paracetamol) 500mg effervescent tablets, EL(24)A/51. Issued 28 October 2024. Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets. This notification is in addition to EL 24(A)/49 and provides further information in relation to the impacted product mentioned in this notification.

Article citation: MHRA Safety Update volume 18, issue 4: November 2024: 2