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Napp Pharmaceuticals Limited have identified an error relating to the Braille printed on the cartons. The
Braille message on the Oxycontin 20mg prolonged release tablets incorrectly states strength as 15mg.
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DEMO SA PHARMACEUTICAL INDUSTRY has informed us that the Product Code/GTIN (PC) number found on the above batch is incorrect. The GTIN number that should have been allocated for this batch is 5200040321010.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 May 2022.
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Consilient Health UK Ltd is recalling a specific batch due to limited units from the batch being distributed prior to batch release.
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Orifarm UK have informed us of an error with the Patient Information Leaflet (PIL) packaged within the packs of certain batches. The product name stated in the heading of the PIL has been spelt incorrectly as “lorazolam”, in…
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The MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequ…
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hameln pharma ltd are recalling batches of product additional to the batch recalled on 15 February 2022 (reference EL(22)A/06).
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Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 May 2022.
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GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.
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Quadrant Pharmaceuticals Ltd are recalling a specific batch of Mefenamic Acid 500mg Film-Coated Tablets as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the t…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 May 2022
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Summary List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 May 2022
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Pfizer Limited are recalling all batches of Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets as a precautionary measure
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Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 April 2022
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Fresenius Kabi Limited are recalling a specific batch of product as a precautionary measure due to the identification of particles in the solution for injection, following routine batch analysis and subsequent batches manufa…
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Crescent Pharma Limited are recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 April 2022
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Pfizer Limited have informed the MHRA that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the specific batches mentioned in this notification.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 April 2022
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Summary List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 April 2022
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USV UK Limited are recalling specific batches of products as a precautionary measure due to out of specification results for impurities during routine stability testing.
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The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia.
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List of field safety notices (FSNs) from medical device manufacturers from 28 March to 1 April 2022.
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List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 March 2022.
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Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.
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List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 March 2022.
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Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack.
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Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 March 2022.
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Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.
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CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on the cartons.
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Boots have identified an error with the printed patient information leaflet provided with batches of the Decongestant Tablets and Decongestant with Pain Relief Tablets.
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List of field safety notices (FSNs) from medical device manufacturers from 28 February to 4 March 2022.
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Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 February 2022.
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Kyowa Kirin Services Ltd. are recalling a batch of Isotard 60mg XL Tablets as a precautionary measure due to microfibres/crystals of the Active Pharmaceutical Ingredient (API) being present on the surface of the tablets as a…
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Atnahs Pharma UK Limited have identified additional missing information on the PIL of the certain product batches.
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List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 February 2022.
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medac GmbH (t/a medac Pharma LLP) are recalling certain product batches as a precautionary measure due to visual detection of glass lamellae particles during an ongoing stability study.
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The MHRA are aware of instances of Surdial X machines removing excess fluid via ultrafiltration outside of its specification. There is a risk to patients who are unable to tolerate excess fluid removal.
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The MHRA has become aware that Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK are being sold with a falsely applied CE mark. This means that these devices have been sold wit…
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Uni Health Distribution is aware of a potential issue where the leaflet contained within Efudix 5% w/w cream (2 x 20g) pack, batch 80193439/B may be incorrect.
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List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 February 2022.
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hameln pharma ltd is recalling a batch of a product as a precautionary measure as remaining vials may no longer be in line with the licensed product specification
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Mawdsley-Brooks & Company Limited (UK importer) is recalling a specific batch of this product as a precautionary measure due out of specification result for pH that was identified during routine stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 31 January to 4 February 2022.
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Atnahs Pharma UK Limited have identified missing information on the PIL of the above batches.
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Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets.
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List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 January 2022.
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Antibiotice SA have identified an error on PIL of the above batches regarding the sodium content.