-
List of Field Safety Notices (FSNs) from 29 May to 2 June 2023
List of Field Safety Notices (FSNs) from 29 May to 2 June 2023
-
List of Field Safety Notices (FSNs) from 22 to 26 May 2023
List of Field Safety Notices (FSNs) from 22 to 26 May 2023
-
Class 3 Medicines Recall: Tricodent Limited (supplier), Medical Oxygen B.P (MEDIGAS OXYGEN B.P), EL (23)A/20
The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.
-
Class 4 Medicines Defect Information: Drugsrus Limited / Dawa Limited, Metronidazole 200 mg/5 ml Oral Suspension, EL (23)A/19
Drugsrus Limited has informed the MHRA that a small number of bottles of Metronidazole 200 mg/5 ml Oral Suspension 100ml are leaking from the cap.
-
Field Safety Notices: 15 to 19 May 2023
List of Field Safety Notices (FSNs) from 15 to 19 May 2023
-
Class 4 Medicines Defect Information: Orifarm UK Ltd, Buccolam 10mg Oromucosal solution, EL (23)A/18
Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use.
-
National Patient Safety Alert: Removal of Philips Health Systems V60 and V60 Plus ventilators from service: risk of shutdown leading to complete loss of ventilation (NatPSA/2023/005/MHRA)
The MHRA is issuing updated advice that Philips Respironics V60 and V60 Plus non-invasive ventilators must be permanently removed from use.
-
Class 4 Medicines Defect Information: Novartis Pharmaceuticals, Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion, EL (23)A/17
Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm i…
-
Field Safety Notices: 8 to 12 May 2023
List of Field Safety Notices (FSNs) from 8 to 12 May 2023
-
Field Safety Notices: 1 to 5 May 2023
List of Field Safety Notices (FSNs) from 1 to 5 May 2023
-
Class 3 Medicines Recall: Hikma Farmacêutica Portugal S.A., Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial, EL(23)A/16
Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification.
-
National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure, NatPSA/2023/004/MHRA
Pharmaswiss Česka republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors.
-
Alert Search Field Safety Notices: 24 to 28 April 2023
List of Field Safety Notices (FSNs) from 24 to 28 April 2023.
-
Field Safety Notices: 17 to 21 April 2023
List of Field Safety Notices (FSNs) from 17 to 21 April 2023.
-
Class 4 Medicines Defect Information: Omega Pharma Ltd, Beconase Hayfever Nasal Spray, EL (23)A/15
Omega Pharma Ltd has identified that there is text missing in Section 2 of the Patient Information Leaflet (PIL) in packs of Beconase Hayfever Nasal Spray (P).
-
Class 4 Medicines Defect Information: Sandoz Limited, Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension, EL (23)A/14
Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’ text was added to the carton in December 2008 in error.
-
Company led medicines recall: Spectrum Therapeutics UK, Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine], CLMR (23)A/04
The importer and distributor of the above products has informed us of reports that the microbial limit for Total Microbial Aerobic Count (TAMC) has been tested to exceed the predefined limit of 200 CfU/g as per the prod…
-
Field Safety Notices: 10 to 14 April 2023
List of Field Safety Notices (FSNs) from 10 to 14 April 2023.
-
NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems: UK Suspension Lifted, DSI 2023/006
The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the PRECICE Titanium subset of devices (Intra-Medullary Limb Lengthening (IMLL), Short, Unyte …
-
Field Safety Notices: 3 to 7 April 2023
List of Field Safety Notices (FSNs) from 3 to 7 April 2023.
-
Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica (UKRP: Bridge to Life): Contamination of fluid (update to DSI/2023/002), DSI/2023/005
The MHRA is providing an update on defects identified with Belzer solutions, manufactured by Carnamedica (UK Responsible Person Bridge to Life).
-
Field Safety Notices: 27 to 31 March 2023
List of Field Safety Notices (FSNs) from 27 to 31 March 2023.
-
Class 4 Medicines Defect Information: Ethigen Limited, Briviact 75mg & 100mg film-coated tablets, EL(23)A/13
Ethigen Limited have informed the MHRA that the Patient Information Leaflet (PIL) in Briviact 75mg and Briviact 100mg film coated tablets contains incorrect or missing information.
-
Field Safety Notices: 20 to 24 March 2023
List of Field Safety Notices (FSNs) from 20 to 24 March 2023
-
Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, GONAPEPTYL Depot 3.75mg, Powder and solvent for suspension for injection, EL(23)A/12
Ferring Pharmaceuticals Limited is recalling certain batches of GONAPEPTYL Depot 3.75mg due to a defect noticed in the seal of the needle wrapping for the CE-marked 30-millimeter (30mm) needle for subcutaneous injection that…
-
Field Safety Notices: 13 to 17 March 2023
List of Field Safety Notices (FSNs) from 13 to 17 March 2023
-
Class 3 Medicines Recall: Rosemont Pharmaceuticals Limited, Sildenafil 10mg/ml Oral Suspension, EL(23)A/11
Rosemont Pharmaceuticals Limited has informed the MHRA that the Press In Bottle Adaptor (PIBA) supplied with the pack (carton) of a specific batch is too wide to fit the neck of the medicine bottle.
-
Field Safety Notices: 6 to 10 March 2023
List of Field Safety Notices (FSNs) from 6 to 10 March 2023
-
Class 4 Medicines Defect Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 150mg, 225mg, 300mg prolonged-release tablets, EL(23)A/10
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 represent…
-
Class 2 Medicines Recall: Various Marketing Authorisation Holders, pholcodine-containing products, EL (23)A/09
Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution.
-
Class 4 Medicines Defect Information: Drugsrus Limited, Clexane 10,000 IU (100mg) / 1ml Syringes, EL(23)A/08
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.
-
Class 4 Medicines Defect Information: Thornton & Ross Ltd, Methadone 1mg/mL Oral Solution BP - Sugar Free, Methadone Mixture 1mg/ml , EL(23)A/07
Thornton & Ross Ltd has informed the MHRA that specific batches of Methadone 1mg/mL Oral Solution BP Sugar Free and Methadone Mixture 1mg/ml, have been packaged with the incorrect Product Information Leaflet (P…
-
Field Safety Notices: 27 February to 3 March 2023
List of Field Safety Notices (FSNs) from 27 February to 3 March 2023.
-
Field Safety Notices: 20 to 24 February 2023
List of Field Safety Notices (FSNs) from 20 to 24 February 2023
-
Class 2 Medicines Recall: Teva UK Limited, Levothyroxine 12.5mcg Tablets, EL (23)A/06
Teva UK Limited is recalling one batch of Levothyroxine 12.5mcg Tablets in response to a lower than required assay result discovered during routine stability testing.
-
Company led medicines recall: Vertical Pharma Resources Ltd T/A IPS Pharma, Levothyroxine Oral Suspension (Various Strengths) [unlicensed medicine], CLMR(23)A/03
IPS Pharma is recalling specific batches of levothyroxine oral suspension from pharmacies and impacted patients due to the concentration of levothyroxine being greater than the amount stated on the label.
-
Class 4 Medicines Defect Information: Atnahs Pharma UK, Zestoretic 20mg/12.5mg Tablets, EL (23)A/05
Atnahs Pharma UK has informed the MHRA that the Patient Information Leaflet (PIL) packaged in certain batches of Zestoretic 20mg/12.5mg Tablets contains outdated safety information.
-
Class 4 Medicines Defect Information: Reckitt Benckiser Healthcare (UK) Limited, Lemsip Max Cold and Flu Capsules, EL (23)A/04
Reckitt Benckiser Healthcare (UK) Limited has informed the MHRA that a typographical error has been identified on the end flap of the outer carton of some batches of Lemsip Max Cold & Flu Capsules.
-
Field Safety Notices: 13 to 17 February 2023
List of Field Safety Notices (FSNs) from 13 to 17 February 2023
-
BD BodyGuard MicroSets and residual ethylene oxide: devices may continue to be used to treat paediatric patients 5kg and above, DSI/2023/004
As a precautionary measure, following an MHRA assessment of currently available data on EO levels, alternative devices to the BD BodyGuard Microsets should be sought in users of 5kg bodyweight and below.
-
NexGen Knee replacement: affected patients should be offered additional follow up, DSI/2023/003
The National Joint Registry (NJR) has identified that both the NexGen® Stemmed Option Tibial Components, when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Fem…
-
Field Safety Notices: 6 to 10 February 2023
List of Field Safety Notices (FSNs) from 6 to 10 February 2023.
-
Field Safety Notices: 30 January to 3 February 2023
List of Field Safety Notices (FSNs) from 30 January to 3 February 2023.
-
National Patient Safety Alert: NIDEK EyeCee One preloaded and EyeCee One Crystal preloaded Intraocular Lenses (IOLs): risk of increased intraocular pressure (NatPSA/2023/003/MHRA)
The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs), which are manufactured by NIDEK and distribute…
-
Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica (UKRP: Bridge to Life): Contamination of fluid; DSI/2023/002
Carnamedica has identified issues with third-party suppliers, which could result in microbiological contamination, particulate matter within the solution, and leakage of fluid.
-
Field safety notice (FSN) 23 to 27 January 2023
Field Safety Notices (FSNs) from 23 to 27 January 2023
-
Field Safety Notice: 26 January 2023
Field Safety Notices (FSNs) from 26 January 2023.
-
EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs): stop using immediately and quarantine all preloaded EyeCee One lenses DSI/2023/001
The MHRA is aware of reports of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs).
-
Company led medicines recall: Prulab Pharma Limited, Clopidogrel Oral Solution 75mg in 5ml [unlicensed medicine], CLMR (23)A/02
Prulab Pharma Limited is recalling a batch of Cloipidogrel Oral Solution 75mg in 5ml due to a discrepancy with the product labelling that could result in an incorrect volume to be administered to the patient.
-
Class 3 Medicines Recall: Dr Reddy’s Laboratories (UK) Ltd, Lacidipine 4 mg Film-Coated Tablets, EL (23)A/03
Dr Reddy’s Laboratories (UK) Limited is recalling two batches of Lacidipine 4 mg Film-Coated Tablets as a precautionary measure due to the presence of an unknown solvent-like odour.