-
Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets.
-
(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)
-
(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)
-
Summary of the latest safety advice for medicines and medical device users
-
(Sanofi Pasteur MSD) Some batches may have antigen levels below required specification – class 2 action within 38 hours. (EL (12)A/33)
-
(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)
-
Summary of the latest safety advice for medicines and medical device users
-
(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 …
-
(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)
-
(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)
-
(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)
-
…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)…
-
Summary of the latest safety advice for medicines and medical device users
-
(ITH Pharma Ltd) Small number of reported cases of bacillus cereus septicaemia affecting neonates - class 1 action now. (EL (14)A/05)
-
Summary of the latest safety advice for medicines and medical device users
-
(ViroPharma SPRL) Pharmacists should quarantine batches and return them to original wholesaler for credit - class 2 action within 48 hours. (EL (14)A/12)
-
(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)
-
Summary of the latest safety advice for medicines and medical device users
-
(Zentiva) Pharmacists should quarantine remaining stock and return to original wholesaler (EL (15)A/13)
-
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.
-
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…
-
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.
-
(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).
-
A list of all medical device alerts that were archived in October 2016.
-
Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL).
-
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.
-
(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…
-
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)
-
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…
-
(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)
-
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.
-
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.
-
Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 - 31 March 2017
-
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…
-
List of field safety notices (FSNs) from medical device manufacturers from 28 March to 01 April.
-
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.
-
Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
-
List of Field Safety Notices from 28 April to 2 May 2025.
-
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.
-
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…
-
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 …
-
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.
-
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.
-
Chanelle Medical Unlimited Company has informed the MHRA of an error with the European Article Number (EAN) / Global Trade Item Number (GTIN) barcode on certain batches of Fexofenadine Hydrochloride 120mg film-coated tablets…
-
List of Field Safety Notices from 1 to 5 January 2024.
-
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…
-
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.
-
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…
-
There is the potential for a black residue to be present on all Medoject hypodermic and blunt fill needles