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LTC Healthcare has informed the MHRA that they have been selling a medicinal product containing lidocaine without authorisation from the MHRA.
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The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.
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Sanofi is recalling batch number A9306 of the above product as a precautionary measure due to an out of specification result detected for Rasburicase enzyme activity according to a specific method and specifications for US market, at 12 months stability time point.
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Pharmaram Ltd has informed us that a specific batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe.
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Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.
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Recalls of medicines issued by manufacturers.
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Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification.
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Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution f…
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Lupin Healthcare (UK) Limited has informed us that the affected batches of Simvastatin tablets have been packaged with a version of patient information leaflet that does not include the most up to date safety information.
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Recalls of medicines issued by manufacturers.
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Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process.
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Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton.
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PCCA Limited have been made aware of an issue with the appearance of Ketamine 50mg in 5ml Oral Solution and Ketamine 100mg in 5ml Oral Solution.
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Glaxo Wellcome UK Ltd T/A GSK has informed us of an issue related to error in the decommissioning of the K84X batch.
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CD Pharma Ltd have notified the MHRA of an error on the outer carton of the product for the batches listed in this notification. While the total active content statement is correct, the delivered dose content statement is in…
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Sun Pharma UK Ltd has informed the MHRA of a labelling issue with one batch of Gemcitabine 2000mg/200ml infusion.
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Glenmark Pharmaceuticals is recalling specific batches as a precautionary measure.
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Sandoz Ltd. have been notified of a potential packaging problem relating to poor seal adherence which could cause clumping of the powder within the bottle.
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The importer and distributor of the above products (Eaststone Limited) has informed us of reports that two affected batches may be contaminated with mould.
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Hospira UK Limited (Pfizer) is recalling specific batches as a precautionary measure.
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…AMCo are recalling the listed batches of Maxolon 5mg/ml as the outer carton contains incorrect administration instructions.…
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Biogen Idec UK is recalling batches as a precautionary measure due to a manufacturing issue.
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Bayer is recalling the listed batches due to reduced potency of the active ingredient
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Precautionary recall because a glass particle has been identified in one syringe from this batch.
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…As this does not impact the full batch, as a precautionary measure Fresenius Kabi are recalling all packs from this batch number.
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Specific batch distributed by Sandoz Ltd is being recalled due to particulate matter found in samples.…
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…Takeda UK Ltd is recalling specific batches of Rienso 30mg/ml solution for infusion (Ferumoxytol).…
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CSL Behring is recalling the listed batches due to reduced potency of the active ingredient.
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Ferring Pharmaceuticals Limited is recalling all batches of Bravelle 75IU powder for solution for injection on the UK market.
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…(Special Products Ltd) A batch of Epistatus 10mg in 1ml Oromucosal Solution is being recalled due to the wrong size of neck adaptor in some bottles (EL (16)A/06)…
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Sanofi is recalling a specific batch of syringe barrels used in batch 4LL66 of this product, distributed from 12 January 2015.
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…(OPD Laboratories Limited) Recall as some packs have incorrectly-labelled blister strips – class 2 action within 48 hours. (EL (13)A/01)…
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Beecham Group plc trading as GlaxoSmithKline UK is recalling specific batches of Bactroban 2% Nasal Ointment 3g and Bactroban 2% Cream 15g.…
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Teva UK Limited is recalling 2 batches as a precautionary measure after visible particles were found during testing.…
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The above batch is being recalled because an out of specification result for sub visible particles was recorded at the 39 month time point
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Hospira UK Limited is recalling 2 specific batches after atypical results for impurities were identified during routine testing.…
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…(RelonChem Ltd/ Kent Pharmaceuticals) All unexpired batches of 50mg Tramadol capsules are being recalled due to the risk of fungal contamination. Class 2 – action within 48 hours. (EL (15)A/04)…
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Accord Healthcare Limited is recalling a specific batch which has inadvertently been distributed in the UK, because it is labelled for the Portuguese market.
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Baxter is recalling a batch of Cernevit powder for solution for injection or infusion as a precautionary measure after receiving 2 complaints of glass particles in vials.
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Specific batch manufactured by Syner-Medica Ltd is being recalled due to concerns it may go out of specification for potency before it expires.
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…The MHRA is advising that Emerade devices should not be recalled.
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…(Merck Sharp & Dohme Ltd) Being recalled as a precaution because results of assays for routine stability studies did not comply with required specification class 3 action within 5 days. (EL (13)A/03)…
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…Sanofi is recalling the A5545 batch of Rifadin because an investigation of out of trend results indicated that it was contaminated with chilled water circulating in the jacket of the reactor during manufacture. (EL(16)A/04)…
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…(Reckitt Benckiser (UK) Ltd) Recall of all unexpired stock of Nurofen Plus tablets in any pack size – class 1 action now. (EL(11)A/21)…
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Macopharma is recalling certain batches of intravenous infusion bags as a precaution. This is due to the detection of metal particles in two infusion bags.
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…Braun Medical Ltd is Recalling batches as ongoing stability studies have identified that they may have an out of specification result in the glucose chamber at the end of shelf-life.
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B Braun Medical Ltd is recalling the above batch as a precautionary measure because the Company has received isolated reports of patient reactions (fever, shivering) associated with administration of the batch.…
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…Ecolab are recalling batches of Klerpack BD Syringe Multi-Pack as the sterile packaging may contain small holes in the film of the pouch. (EL (16)A/13)…
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…GlaxoSmithKline UK are recalling multiple batches of 125ml bottles of the above product. This is due to incorrect dosing instructions on the patient information leaflet advising patients to take half the recommended dose - class 2 action within 48 hours. (EL (12)A/25)…
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Pfizer UK Limited is recalling batches as routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.