Letters and medicine recalls sent to healthcare professionals in July 2024

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

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

Class 3 Medicines Recall: Accord Healthcare Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules, EL(24)A/25. Issued 2 July 2024. Accord Healthcare Ltd is recalling various batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents beyond permitted levels.

Class 2 Medicines Recall: Kent Pharma UK, Itraconazole 10mg/ml Oral Solution, EL(24)A/26. Issued 4 July 2024. Kent Pharma UK is recalling various batches of Itraconazole 10mg/ml Oral Solution as a precautionary measure due to out of specification in the appearance of the solution, particularly the presence of suspended particles or clusters of crystals.

Class 4 Medicines Defect Information: Chelonia Healthcare Limited, Propantheline Tablets 15mg (Genesis Pharmaceuticals livery), EL(24)A/27. Issued 9 July 2024. Chelonia Healthcare Limited has informed the MHRA that an error relating to the product description was identified in the Patient Information Leaflet (PIL) for the batches listed in this notification. In the PIL supplied, the product is described as being “pale pink in colour”, whereas the tablet is actually orange in colour.

Class 2 Medicines Recall: Sun Pharma UK Limited, Gemcitabine PPF 1800mg/180mL Infusion; Gemcitabine PPF 1600mg/160mL Infusion; Irinotecan PPF 360mg/240mL Infusion, EL(24)A/28. Issued 15 July 2024. Sun Pharma UK Ltd is recalling certain batches as a precautionary measure due to a small number of leaks found intermittently in the infusion bags.

Class 2 Medicines Recall: Sun Pharma UK Limited, Pemetrexed 1000MG/100ML (10mg/ml) & 1100MG/100ML (11mg/ml) Infusion Bag, EL(24)A/29. Issued 16 July 2024. Sun Pharmaceutical Industries Europe B.V. is recalling the listed batches as a precautionary measure due to visible particulate matter during stability testing.

Class 2 Medicines Recall: Glaxo Wellcome UK Limited (trading as GlaxoSmithKline UK), Flolan 1.5 mg Powder and Solvent for Solution for Infusion, EL(24)A/30. Issued 22 July 2024. Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process.

Class 4 Medicines Defect Information: Fresenius Kabi Limited, Hartmann’s Solution for Injection BP as Steriflex No. 11 or freeflex, EL(24)A/31. Issued 24 July 2024. Fresenius Kabi Limited has informed the MHRA of a labelling error on the packaging of Hartmann’s solution for Injection BP as Steriflex No.11 or freeflex. The calcium content in the active ingredient section of the infusion bag label is incorrectly stated as ‘12 mmol/500 mL’; this should state ‘1 mmol/500 mL’.