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(Actavis UK Ltd) Use of incorrect blister foil which fails to meet the specification for child resistancen – class 2 action within 48 hours. (EL (12)A/24)
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Summary of the latest safety advice for medicines and medical device users
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(Eli Lilly Nederland B.V.) Remaining stocks of affected batch should be quarantined and returned to original supplier for credit – class 2 action within 48 hours. (EL (13)A/22)
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(Reckitt Benckiser Healthcare (UK) Limited) Remaining stock of batches should be quarantined and returned to original supplier for credit. - class 2 action within 48 hours. (EL (14)A/08)
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(Lundbeck Limited) May result in suboptimal dosage of the product - class 2 action within 48 hours. (EL (14)A/19)
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(ITH Pharma Ltd) Remaining stocks should be quarantined and returned to original supplier for credit - class 2 action within 48 hours. (EL (14)A/06)
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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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(Merck Sharp & Dohme Ltd) Study showed failure to reduce major vascular events and increase in non-fatal serious adverse events – class 2 action within 48 hours. (EL (13)A/02)
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(Sanofi-aventis) Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/07)
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(Bayer Consumer Care Division) Two batches inadvertently placed on the market containing patient information leaflet (PIL) for prescription only medicine (POM) product - class 4 caution in use. (EL(11)A/17)
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(Novartis Consumer Health UK Limited and Actavis Group PTC EHF): Product reclassified from P to POM due to safety concerns – class 2 action within 48 hours (EL (15)A/01)
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(Cambridge Healthcare Supplies Limited on behalf of Typharm Limited) Remaining stocks of the affected batches should be quarantined and returned to Cambridge Healthcare Supplies Limited – class 2 action within 48 hours. (EL …
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(Novartis Pharmaceuticals UK) Increased risk of malignancies with long -term use of calcitonin – class 2 action within 48 hours. (EL 13(A)11)
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(Sanofi Pasteur MSD) Some batches may have antigen levels below required specification – class 2 action within 38 hours. (EL (12)A/33)
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(Mylan) Carton incorrectly states "For children 2 to 5 years" but patient information leaflet (PIL) correctly states "For children 6 to 14 years" – class 2 action within 48 hours. (EL (13)A/08)
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Following our latest review of medical device alerts, we have archived the ones listed below.
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(B Braun Melsungen AG and Fresenius Kabi Limited) Increased risk of renal dysfunction and mortality in critically ill or septic patients– class 1 action within 48 hours. (EL (13)A/18)
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Summary of the latest safety advice for medicines and medical device users
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(ALK-Abelló A/S) Potential problem with delivery of dosage following activation of auto injector. Class 2 action within 48 hours (EL (13)A/28)
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(Wockhardt UK Limited) Remaining stocks of affected batches should be quarantined and returned to original supplier for credit – class 2 action within 48 hours (EL (13)A/19)
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Summary of the latest safety advice for medicines and medical device users
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…In addition, due to connector leakages, the manufacturer is recalling extension sets (specific product codes and batches) used with the T34 pumps (MDA/2016/002)…
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(ITH Pharma Ltd) Small number of reported cases of bacillus cereus septicaemia affecting neonates - class 1 action now. (EL (14)A/05)
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(Zentiva) Pharmacists should quarantine remaining stock and return to original wholesaler (EL (15)A/13)
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(ViroPharma SPRL) Pharmacists should quarantine batches and return them to original wholesaler for credit - class 2 action within 48 hours. (EL (14)A/12)
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Summary of the latest safety advice for medicines and medical device users
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(Novo Nordisk A/S) Patients who may have received the affected batches should be contacted and asked to check their supply – class 2 action within 48 hours. (EL (13)A/25)
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Summary of the latest safety advice for medicines and medical device users
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(Allergan Limited) Small number of complaints have been received about small black particles found on or around the nozzle of the tube (EL (15)A/08).
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The MHRA is providing an update on the issue of increased intraocular pressure in patients implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses.
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Crescent Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of simvastatin 10 mg Tablets distributed by Alliance Healthcare UK.
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(Pfizer Limited) Defect found to create the possibility of the dose being set to one extra click beyond the dose selected and indicated in the memory window when the patient turns the dose knob with excessive force (EL (15)A…
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The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic…
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A list of all medical device alerts that were archived in October 2016.
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Rosemont Pharmaceuticals Limited has informed the MHRA that the Press-In-Bottle-Adaptor (PIBA) supplied with the batches listed above may cause the medicine to leak when attempting to withdraw a dose.
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Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)
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Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL).
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Zydus Pharmaceuticals UK LTD has informed the MHRA that there is an error on the artwork for the outer carton and Patient Information Leaflet (PIL) of Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution (pack size 150m…
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Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
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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.
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(Teva UK Limited) Remaining stock should be quarantined and returned to original supplier for credit – class 3 action within 5 days. (EL (13) A/21)
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USV UK Limited has informed the MHRA that Sugammadex 100 mg/ml solution for injection (2 ml vial), batch number 35000347, may contain some vials that contain a low volume of solution; less than the label claim of 2 ml.
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List of field safety notices (FSNs) from medical device manufacturers from 28 March to 01 April.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 - 31 March 2017
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Additional to the batches included in the previous Class 4 Medicines Notification (reference EL(22)A/47), Martindale Pharma has made the MHRA aware that the GTIN in the 2D barcode and the printed variable data represents the…
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Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) in the listed batches of Cozaar 100mg film-coated tablets.
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Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
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List of Field Safety Notices from 28 April to 2 May 2025.
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Flamingo Pharma UK Ltd has identified an error relating to the ink printing of the batch number and expiry date on the carton for three batches of Ibuprofen 400mg Tablets. This notification includes all potentially impacted …
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Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing…