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Gedeon Richter (UK) Ltd is recalling all unexpired stock of Esmya 5 mg tablets from patients, pharmacies and wholesalers following a new case of liver failure requiring liver transplant in a patient taking the medicine.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 March 2020
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Mylan UK Healthcare Ltd has informed us that a product complaint has been received relating to crystalline precipitate being observed during bottle use. Due to concerns with continuity of supply these batches are not being r…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 March 2020
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 150 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 February 2020
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AOP Orphan Pharmaceuticals AG is recalling all unexpired stock of a batch of Tetrabenazine 25 mg tablets (from pharmacies and wholesalers) as a precautionary measure due to out of specification results for the assay, obtaine…
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Manufactured by Cardinal Health – calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.
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Manufactured by Olympus Medical Systems Corp – instructions for use now say to inspect for frayed elevator wires before and after use to improve the detection of damage.
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G.L Pharma GmbH T/A Healthcare Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the specified batches is missing important safety relevant text changes.
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Manufactured by CME (a BD company) – updated advice to address ‘wear and tear’ of the syringe pump motor block which may lead to under-infusion.
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Crescent Pharma Ltd has informed us of a discrepancy on the product packaging.
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Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 February 2020
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Summary List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 February 2020
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Accord Healthcare Ltd has informed us of an issue related to the expiry date for the above batches, which has not been encoded in 2D data matrix.
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Accord-UK Limited is recalling all unexpired stock of Gliclazide 40 mg Tablets (Northstar Livery) from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution, obtained durin…
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Glaxo Wellcome UK Ltd T/A GSK has informed us of an issue related to error in the decommissioning of the K84X batch.
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Accord Healthcare Ltd has informed us that the Patient Information Leaflet (PIL) for all strengths of Atrolak XL Prolonged-release tablets is missing the side effects identified from post-marketing experience.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 February 2020
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Glenmark Pharmaceuticals is recalling specific batches as a precautionary measure.
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List of field safety notices (FSNs) from medical device manufacturers from 27 January to 31 January 2020.
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Medreich Plc is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic …
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Wockhardt UK Ltd is recalling specific batches of Levothyroxine 100micrograms/5ml Oral Solution from pharmacies and wholesalers as a precautionary measure due to notification of the impurity liothyronine exceeding the s…
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Dr Reddy's Laboratories (UK) Ltd has informed us that the Patient Information Leaflet (PIL) for the specific batches listed in this alert are missing the special warning and precautions identified from post-marketing ex…
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List of field safety notices (FSNs) from medical device manufacturers from 20 January to 24 January 2020
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LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy.
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List of field safety notices (FSNs) from medical device manufacturers from 13 January to 17 January 2020
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Caution in Use: Distribute to Pharmacy level. Advanz Pharma has informed us of a discrepancy on the product packaging. The discrepancy relates to “capsules” printed at the top right of the packs in error, instead of tablets
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List of field safety notices (FSNs) from medical device manufacturers from 06 to 10 January 2020.
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List of field safety notices (FSNs) from medical device manufacturers from 30 December 2019 to 3 January 2020.
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List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 December 2019.
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Hospira UK Limited (Pfizer) is recalling specific batches as a precautionary measure.
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Medley Pharma Limited is recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
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List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 December 2019.
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Manufactured by Flexicare Medical – loose bearings and retaining ring may enter patient’s airway causing choking hazard if the laryngoscope blade is disengaged from the handle above the patient.
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List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 December 2019.
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Accord Healthcare are recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
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Manufactured by Terumo BCT – inadequately broken anticoagulant ‘frangible’ may lead to clotting and inadequate therapy during apheresis procedures.
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List of field safety notices (FSNs) from medical device manufacturers from 25 October to 29 November 2019.
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerede Adrenaline Autoinjectors after identifying an error than can cause some pens to fail to activate.
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M&A Pharmachem Limited is recalling all unexpired batches as a precautionary measure, because a small number of pots from some batches have been found to contain discoloured tablets due to fungal contamination.
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List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 November 2019.
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OTC Concepts Ltd, Relonchem Ltd, Noumed Life Sciences Ltd and Medreich Plc. are recalling stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.
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Creo Pharma Limited and Tillomed Laboratories Limited are recalling all unexpired stock of the products listed in this alert.
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List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 November 2019.
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Accord-UK Ltd has informed us of an issue related to decommissioning of the batch below.
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List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 November 2019
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Sandoz Limited is recalling one batch due to the occurrence of degradation in some vials, resulting in green discoloration of the powder in the vial, leading to increased levels of impurities/degradation products in the…
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This recall affects Mitomycin-C Kyowa 2 mg (PL 16508/0042), 10 mg (PL 16508/0043), 20 mg (PL 16508/0044), powder for solution for injection, and Mitomycin-C Kyowa 40 mg (PL 16508/0045), powder for intrave…