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The MHRA has made further changes to the way we issue safety messaging to healthcare providers.
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List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 February 2021
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Orion Corporation T/A Orion Pharma (UK) Ltd are recalling specific batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored.
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Unknown risks following distribution of product after CE certificate withdrawal
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List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 February 2021
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SyriMed are recalling the below batch as a precautionary measure due to an issue related to the container closure (child-lock cap).
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Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled.
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List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 February 2021
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Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-…
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List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 February 2021
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Grünenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall.
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Intrapharm Laboratories Ltd has informed us that they have received complaints that the consistency of a batch of Kolanticon Gel 500ml is lumpy. An investigation and retained samples for this batch show the same homogeneity …
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List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 January 2021
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List of field safety notices (FSNs) from medical device manufacturers from 18 January to 22 January 2021
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CSL Behring UK Ltd is recalling specific batches of Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001) due to a manufacturing deviation that occurred during the filling process.
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Takeda UK Limited is recalling a batch of Instanyl 100mcg nasal spray solution (EU/1/09/531/015) due to the observation of cracked vials during inspection of the bulk vials and release testing of the finished products.
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List of field safety notices (FSNs) from medical device manufacturers from 11 January to 15 January 2021
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List of field safety notices (FSNs) from medical device manufacturers from 04 January to 08 January 2021
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List of field safety notices (FSNs) from medical device manufacturers from 28 December to 31 December 2020
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List of field safety notices (FSNs) from medical device manufacturers from 21 December to 24 December 2020
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Medac Pharma LLP is recalling specific batches of products due to some inspected vials showing hairline damage to the shoulder of the vials. This is a second alert for further batches identified.
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List of field safety notices (FSNs) from medical device manufacturers from 14 December to 18 December 2020
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Fresenius Kabi Ltd is recalling the above batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a prec…
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Merck Sharp & Dohme Limited is recalling specific batches of Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion as a precautionary measure due to the presence of Ralstonia pickettii in recent batches manufa…
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Fairmed Healthcare GmbH has informed us of a discrepancy on the product packaging for some batches. The discrepancy relates to the incorrect spelling of one of the active pharmaceutical ingredients printed on one side of the…
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List of field safety notices (FSNs) from medical device manufacturers from 07 December to 11 December 2020
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Generics [UK] Limited t/a Mylan have informed us that the Patient Information Leaflet (PIL) within the packs for the products listed above is missing relevant important safety information.
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List of field safety notices (FSNs) from medical device manufacturers from 30 November to 4 December 2020.
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Lupin Healthcare (UK) Limited has informed us that the affected batches of Simvastatin tablets have been packaged with a version of patient information leaflet that does not include the most up to date safety information.
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List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 November 2020.
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Sanofi is recalling specific batches of Largactil 50mg/2ml Solution for Injection as a precautionary measure due to out of specification results obtained for the impurity chlorpromazine sulphoxide
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Kent Pharmaceuticals Ltd has informed us that several batches of finished product were contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the fi…
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Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of double tablets in a single blister pocket.
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List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 November 2020.
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List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 November 2020.
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Mylan UK Healthcare Ltd is recalling remaining stock of certain batches as a precautionary measure after a product sterility non-compliance event which occurred during a recent inspection at the contract manufacturing site.
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medac Pharma LLP is recalling a specific batch of products due to some inspected vials showing hairline damage to the shoulder of the vials.
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List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 November 2020.
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Intrapharm Laboratories Ltd has informed us that there is a difference in dosage instructions between the carton and label. The Patient Information Leaflet (PIL) and bottle label contain the correct instructions.
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Regular safety information for healthcare professionals
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List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 October 2020.
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Theramex Ireland Ltd T/A Theramex HQ UK Ltd has informed us of an issue related to error in the decommissioning of a further batch. Upon decommissioning at the pharmacy and when scanning the serialised 2D code, the status of…
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List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 October 2020.
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Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of…
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List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 October 2020.
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This is a new regular bulletin from Medicines and Healthcare products Regulatory Agency (MHRA) to inform health and care professionals of new or ongoing safety issues with medical devices. It is aimed at all parts of the hea…
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Accord Healthcare Ltd has informed us that when decommissioning at the pharmacy and scanning the serialised 2D code, the status of certain packs may report as ‘EXPORT.’
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Sanofi is recalling batches of product as a precautionary measure due to out of specification results for disintegration test during routine stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 5 October to 9 October 2020
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The Boots Company PLC is recalling a specific batch of Hydrocortisone 1% w/w Ointment as a precautionary measure due to retained samples showing presence of Pseudomonas aeruginosa.