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Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.
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).
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
Sun Pharma UK Ltd has informed the MHRA of a labelling issue with one batch of Gemcitabine 2000mg/200ml infusion.
Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA.
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.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
List of Field Safety Notices from15 to 19 April 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.
medac GmbH (t/a medac Pharma LLP) is recalling further batches due to particles detected during long-term stability tests.
List of Field Safety Notices from 20 to 24 May 2024.
medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests.
Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.
List of Field Safety Notices from 3 to 7 June 2024.
Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information.
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