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A. Menarini Farmaceutica Internazionale Srl is recalling a specific batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market.
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Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection.
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Accord Healthcare Ltd is recalling a batch of Ipratropium Bromide 500 microgram/2ml Nebuliser Solution after a foil pouch was found to contain ampoules with incorrect labels intended for the Korean market. The incorrectly la…
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Kent Pharma UK is recalling a batch of phenoxymethylpenicillin 250mg/5mL oral solution sugar free due to a low phenoxymethylpenicillin assay.
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Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Linezolid 600 mg film-coated tablets.
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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).
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Torbay Pharmaceuticals has informed us that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg in 1…
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Blumont Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the batch of Chloramphenicol 1% w/w Eye Ointment (POM version only) in the below table.
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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.
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Martindale Pharma is recalling the below batch of Methadone 5mg tablets as a precautionary measure due to the discolouration of the PVdC film in a small number of blister pockets.
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Error with the patient information leaflet (PIL) that has been provided with Diuril Oral Solution, supplied by Mawdsley-Brooks & Company Limited.
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The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via Kingsley Specials Ltd WDA(H) 49276, who purchased from a company that do…
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GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.
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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-UK Ltd (Trading style: NorthStar) are recalling the above batch of product as a precautionary measure due to tablet hardness failures, leading to crumbling and breaking tablets.
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Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stab…
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Sandoz Limited is recalling one batch due to the occurrence of degradation in some vials, resulting in green discoloration of the powder in the vial, leading to increased levels of impurities/degradation products in the medi…
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Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.
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Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL.
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hameln pharma ltd is initiating a recall of the affected batches of Ephedrine Hydrochloride 30 mg/ml Solution for Injection as a precautionary measure.
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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.
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Viatris has received reports of brown discolouration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to oxidation of the syringe needle.
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Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part of the approved Additional Risk Minimisation Measures …
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Cygnus Pharma Ltd. Have informed MHRA that the European Article Number (EAN) barcode printed on various packs of Trazodone Hydrochloride 50mg/5ml Oral Solution, is defective and returns the incorrect information.
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Accord Healthcare Limited is recalling certain batches of Azacitidine Powder for Suspension for Injection 100 mg/vial and 150 mg/vial as precautionary measure due to out of specification results for Azacitidine related compo…
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Omega Pharma Limited have identified an error relating to the product packaging.
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Bell, Sons & Co is recalling several batches of own-brand children’s blackcurrant cough syrups due to a small number of reports of mould.
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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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Bio Products Laboratory Limited is recalling one batch of Human Rabies Immunoglobulin following a stability failure for this batch. The batch has shown a reduction in potency of the Human Rabies immunoglobulin.
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Chelonia Healthcare Limited has informed the MHRA that an error relating to the product description was identified in the Patient Information Leaflet (PIL) for the batches listed in this notification.
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Wockhardt UK Limited is recalling this batch as a precautionary measure following the identification of a low number of units which may have a defect in the 'top case' resulting in a dose not being able to be dispens…
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Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of th…
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GSK has informed us that due to a machinery defect with the printing line, a small number of packs may not have the batch number and expiry date printed on the outer cartons. The correct information is printed on the blister…
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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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Accord-UK Limited is recalling all unexpired stock of Gliclazide 40 mg Tablets (Northstar Livery) from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution, obtained durin…
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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…
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Takeda UK Limited has informed us that there is an error in the text on the pouch for batches of Matrifen 100 micrograms/hour transdermal patches distributed since 25 May 2013 in Teva UK livery.
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Sun Pharmaceuticals are recalling batches of zoledronic acid due to out of specification results observed for Particulate Matter Test during routine stability testing.
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Gedeon Richter (UK) Ltd is recalling all unexpired stock of Esmya 5 mg tablets from patients, pharmacies and wholesalers following a new case of liver failure requiring liver transplant in a patient taking the medicine.
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Thornton & Ross have identified that the product labelling for some batches of ‘Pharmacy’ medicines do not contain the ‘P’ symbol, due to a packaging error on the bottle.
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Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate for solution for infusion.
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Jubilant Pharmaceuticals NV has informed the MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
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Error relating to the wording on the outer carton label for Mometasone Furoate 50 Microgram / Dose Nasal Spray, supplied by PilsCo Ltd.
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Strides Pharma UK Ltd has informed MHRA of an error in the patient information leaflet (PIL) for Liothyronine Sodium 20 micrograms Tablets and Liothyronine Sodium 5 micrograms Tablets.
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 300 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…
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Max Remedies has identified an infrequent printing error relating to the Braille text printed on the cartons of various batches of this product.
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Boots have identified an error with the printed patient information leaflet provided with batches of the Decongestant Tablets and Decongestant with Pain Relief Tablets.
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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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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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Action within 48 hours: Novo Nordisk Ltd. is recalling seven batches of GlucaGen HypoKit due to a small number of needles being detached from the syringe.