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Pfizer is recalling the above batches as a precaution due to an out of specification result for microbiological testing during routine stability studies on a batch of the product which was not released to the market. (EL (17…
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Pfizer Limited has informed us that the packs for the affected batches below have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions of the infusion so…
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Fresenius Kabi Limited has informed the MHRA of a labelling error on the packaging of Hartmann’s solution for Injection BP as Steriflex No.11 or freeflex.
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Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL).
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Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in…
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…(Special Products Ltd) Packs containing the new syringe to be distributed from September 2012 – class 4 caution in use - class 4 caution in use. (EL (12)A/26)…
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AOP Orphan Pharmaceuticals AG is recalling all unexpired stock of a batch of Tetrabenazine 25 mg tablets (from pharmacies and wholesalers) as a precautionary measure due to out of specification results for the assay, obtaine…
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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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Chemidex pharma ltd has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batches listed in the tables for Ponstan 250mg capsules and Ponstan Forte 500mg tablets include an out of date PIL, …
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The Boots Company PLC is recalling a specific batch of Hydrocortisone 1% w/w Ointment as a precautionary measure due to retained samples showing presence of Pseudomonas aeruginosa.
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Blumont Pharma Limited is reporting to the MHRA regarding the absence of Braille on the outer carton of one batch of Ocumont Eye Ointment 1% w/w (POM). It was identified that the Braille information was inadvertently omitted…
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M & A Pharmachem is recalling the above batches because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination.
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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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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.
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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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Colgate-Palmolive (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL), carton and tube of the batches of Duraphat 5000ppm Fluoride Toothpaste (51g) listed above are missing information relating to…
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Aspar Pharmaceuticals Limited has informed us that the Patient Information Leaflets (PILs) within the ibuprofen packs below are missing some information identified from post-marketing experience that should be documented in …
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Sanofi is recalling all batches of Stemetil 5mg/5ml Syrup as a precautionary measure due to the identification of N-nitrosomethylphenylamine (NMPA) above the acceptable limit.
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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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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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G.L Pharma GmbH T/A Healthcare Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the specified batches is missing important safety relevant text changes.
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LEO Pharma is recalling the affected batch as a precautionary measure due to out of specification results for impurities during routine stability testing.
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Macarthys Laboratories Limited T/A Martindale Pharma has informed us that the EAN barcode on the outer carton of a specific batch of Caffeine Citrate 10mg/ml Solution for Injection is incorrect.
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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.
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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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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…
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Biocon Pharma UK Limited are recalling a specific of batch Posaconazole 100mg Gastro-resistant Tablets due to an out of trend result for unspecified impurities during testing for stability.
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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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Allergan Pharmaceuticals Ireland is recalling specific batches due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached.
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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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Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-…
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Accord Healthcare Limited, UK has informed the MHRA that the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SPC) do not contain all the required safety information.
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Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products.
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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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Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This defect could increase the risk of the applicator device being contaminated with pathogens, which cou…
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Orion Corporation T/A Orion Pharma (UK) Ltd are recalling specific batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored.
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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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All batches of the named products are being recalled by the Marketing Authorisation Holder in Italy and subsequent UK parallel distributor companies as a precautionary measure due to the product being manufactured with the i…
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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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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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Action within 48 hours: patient, pharmacy and retail level recall of St John's Wort tablets. Testing has shown the presence of a toxic pyrrolizidine alkaloid (PA) above the threshold recommended by the Committee on Herba…
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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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SANTEN Oy (trading as Santen UK Limited) are recalling two batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.
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Flynn Pharma Ltd, distributors of Slenyto 1 mg and 5mg prolonged release tablets would like to notify you of an error with the patient information leaflets (PILs) that have been packaged in the below batches of products.
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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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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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Dr Reddy's Laboratories (UK) Ltd has informed us that the Patient Information Leaflet (PIL) for the specific batches listed in this alert are missing the special warning and precautions identified from post-marketing exp…
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Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution due to out of specification stability results.
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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.