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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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(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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(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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(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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(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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…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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(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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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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(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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A list of all medical device alerts that were archived in October 2016.
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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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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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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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Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
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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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(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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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 - 31 March 2017
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List of field safety notices (FSNs) from medical device manufacturers from 28 March to 01 April.
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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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List of Field Safety Notices from 28 April to 2 May 2025.
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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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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…
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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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Drugsrus Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Clexane 10,000IU (100mg)/1 ml Syringes contains a typographical error in the leaflet.
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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.
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The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement.
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List of Field Safety Notices from 1 to 5 January 2024.
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There is the potential for a black residue to be present on all Medoject hypodermic and blunt fill needles
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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.
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Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the batches in the table for Rabeprazole sodium 10mg and 20mg gastro-resistant tablets do not contain the most up to date safet…
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Martindale Pharmaceuticals has informed us of two issues with all unexpired batches of the above product, PL 00156/0109, legal status ‘P’. The Braille is missing from the carton and the packs contain the Patient Information …
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(Auden Mckenzie Ltd) Small number may contain 3 blister strips –class 4 caution in use. (EL (13)A/05)
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Medicines have been taken out of the regulated medicines’ supply chain during distribution. The products have been parallel imported into the UK by B & S Healthcare from Italy and have been re-labelled in B & S Healt…
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(Amdipharm UK Limited) Remaining stock of this batch should be quarantined and returned to the original supplier for credit - class 3 action within 5 days (EL (16)A/15)
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(Teva UK Limited) 25mg has been incorrectly printed in one position of the affected foil packs however is correct in other positions (EL(15)A/07).
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(Teva UK Ltd) Leaflet incorrectly states take 1 or 2 tablets a day. (EL (14)A/01)
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Fresenius Kabi Ltd & Calea UK Ltd has informed us of an error on the bag labels for SmofKabiven extra nitrogen electrolyte free, emulsion for infusion PL 08828/0269.
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Crescent Pharma Ltd has informed us of a discrepancy on the product packaging.
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Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK.
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Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) has informed us of a typographical error in active ingredient stated on the label on the vial.
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Daiichi Sankyo UK Limited has informed us that there is an error on the blister foil of specific batches of Olmetec 20mg Film-Coated Tablets
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Macarthys Laboratories Limited T/A Martindale Pharma has informed us that the EAN barcode on the outer carton of a specific batch of Caffeine Citrate 10mg/ml Solution for Injection is incorrect.
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List of field safety notices (FSNs) from medical device manufacturers from 14 March to 18 March 2016.
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(Laboratoire SERB) EAN barcode is incorrect – when scanned, it identifies the product as Primidone SERB 250mg tablets not 50mg tablets (EL (15)A/10)
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Martindale Pharma has made the MHRA aware that the GTIN in the 2D barcode and the printed variable
data represents the branded version of the product (Venlalic® XL 300 mg prolonged-release tablets).