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Accord Healthcare Ltd is recalling various batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule content…
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PHARMATHEN S.A. has informed the MHRA that the outer carton (box) of some batches of Grepid 75mg film coated tablets is missing the medicines legal classification for a Prescription Only Medicine ‘POM.’ This notification con…
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Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for commercial reasons.
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Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150 mg, 300 mg & 600 mg Film-Coated Tablets do not contain the most up to…
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Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL).
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Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testin…
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Neuraxpharm UK Ltd is recalling specific batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents …
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Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated in the table.
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Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination.
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Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed.
There are numerous counterfeit and unbranded anti-choking devices being sold in the UK o…
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Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA.
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Atnahs Pharma UK Ltd has informed the MHRA that the batches of Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension listed in this notification do not contain the most up to date safety information.
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Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Clarithromycin 250mg and 500mg film-coated tablets.
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Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Tramadol Hydrochloride 50mg Capsules, Hard.
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Teva UK Ltd. has informed the MHRA of a labelling error. This notification provides further advice on the safe use of the product.
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AstraZeneca UK Ltd. has informed the MHRA of an issue related to the expiry dates for certain batches of Fluenz Tetra. This recall provides further advice on the safe use of the product up to the amended expiry date.
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Specific batches of carbomer gel are being recalled as a precaution due to possible
microbiological contamination.
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Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information.
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The SteriFeed colostrum collection device is intended to be used only to collect and store colostrum. It should not be used as an infant feeding device as the cap, if not removed, can easily get dislodged and become stuck in…
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Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating.
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Veriton Pharma Limited is recalling a specific batch of Epistatus (midazolam) 2.5mg Oromucosal Solution (pre-filled oral syringes) due to confirmed out of specification results related to the product appearance.
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The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.
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Attaching an incompatible needle-free connector (NFC) to an Ethypharm Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs should be used with pre-fille…
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B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification.
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Sanofi UK is recalling the listed batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of manufacturer for vigabatrin.
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Cipla (EU) Limited, UK and Pharmathen S.A. have informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medic…
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Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets due to an error on the foil blister packaging.
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Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch in this notification state 8 tablets instead of 4 tablets.
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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.
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Pharmaswiss Česka republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors.
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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.
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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 product s…
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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 …
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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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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.
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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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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 (PIL).
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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.
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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.
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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.
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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.
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Field Safety Notices (FSNs) from 26 January 2023.
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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.
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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.
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UCB Pharma Ltd is recalling one batch of Dioctyl 100 mg Capsules as a precautionary measure due to the presence of a foreign capsule being found in a sealed pack.
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Albireo AB has informed the MHRA that there is a typographical error with the text on the side panel of the bottle label for a specific batch of Bylvay 1200 micrograms Hard Capsules.
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Galderma (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in some batches of Epiduo 0.1% / 2.5% gel contain outdated safety information regarding pregnancy.
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Galderma (U.K.) Limited has informed the MHRA that the patient information leaflet (PIL) packaged in specific batches of Etrivex Shampoo is missing safety information
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ADVANZ PHARMA has made the MHRA aware that certain batches of MacroBID 100mg Prolonged-Release Capsules have been packed with the incorrect Patient Information Leaflet (PIL).
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Lucis Pharma Ltd has informed the MHRA that there is a typographical error with text on the rear side of the outer packaging for Oxycodone Hydrochloride 10mg/ml Oral Solution.