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Rosemont Pharmaceuticals Ltd. has made the MHRA aware that the expiry dates stamped on the base of the bottle are incorrect for 2 batches of Atorvastatin 4mg/ml Oral Suspension and 2 batches of Sildenafil 10mg/ml O…
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Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in various parallel imported batches.
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Hikma Pharmaceuticals USA Inc are recalling the below batches due to an out of specification result with related substances during testing for retain samples.
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The UK Marketing Authorisation Holder has confirmed that a batch of Dysport 500 Units Powder for Solution for Injection is falsified and has been supplied by unauthorised distributors to the UK.
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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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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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Stockport Pharmaceuticals are recalling a batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (January 2022).
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Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.
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Omega Pharma Limited have identified an error relating to the product packaging.
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hameln pharma ltd is initiating a recall of batch 207506 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure.
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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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A.Vogel Ltd is recalling a specific batch of Pharmacy only medicine due to a small number of packs that were inadvertently supplied to non-pharmacy retail outlets.
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Altan Pharma Limited have identified an error relating to the product packaging. The incorrect concentration of phenylephrine base is provided on the overwrapping bag label.
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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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Bristol Laboratories Limited are recalling a batch of this product as a precautionary measure due to low dissolution test results reported during ongoing stability studies.
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Napp Pharmaceuticals Limited have identified an error relating to the Braille printed on the cartons. The
Braille message on the Oxycontin 20mg prolonged release tablets incorrectly states strength as 15mg.
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DEMO SA PHARMACEUTICAL INDUSTRY has informed us that the Product Code/GTIN (PC) number found on the above batch is incorrect. The GTIN number that should have been allocated for this batch is 5200040321010.
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Consilient Health UK Ltd is recalling a specific batch due to limited units from the batch being distributed prior to batch release.
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Orifarm UK have informed us of an error with the Patient Information Leaflet (PIL) packaged within the packs of certain batches. The product name stated in the heading of the PIL has been spelt incorrectly as “lorazolam”, in…
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The MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequ…
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hameln pharma ltd are recalling batches of product additional to the batch recalled on 15 February 2022 (reference EL(22)A/06).
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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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Quadrant Pharmaceuticals Ltd are recalling a specific batch of Mefenamic Acid 500mg Film-Coated Tablets as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the t…
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Pfizer Limited are recalling all batches of Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets as a precautionary measure
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Fresenius Kabi Limited are recalling a specific batch of product as a precautionary measure due to the identification of particles in the solution for injection, following routine batch analysis and subsequent batches manufa…
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Crescent Pharma Limited are recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure.
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Pfizer Limited have informed the MHRA that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the specific batches mentioned in this notification.
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USV UK Limited are recalling specific batches of products as a precautionary measure due to out of specification results for impurities during routine stability testing.
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Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.
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Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack.
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Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during stability testing.
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Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.
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CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on the cartons.
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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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Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability testing.
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Kyowa Kirin Services Ltd. are recalling a batch of Isotard 60mg XL Tablets as a precautionary measure due to microfibres/crystals of the Active Pharmaceutical Ingredient (API) being present on the surface of the tablets…
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Atnahs Pharma UK Limited have identified additional missing information on the PIL of the certain product batches.
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medac GmbH (t/a medac Pharma LLP) are recalling certain product batches as a precautionary measure due to visual detection of glass lamellae particles during an ongoing stability study.
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Uni Health Distribution is aware of a potential issue where the leaflet contained within Efudix 5% w/w cream (2 x 20g) pack, batch 80193439/B may be incorrect.
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hameln pharma ltd is recalling a batch of a product as a precautionary measure as remaining vials may no longer be in line with the licensed product specification
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Mawdsley-Brooks & Company Limited (UK importer) is recalling a specific batch of this product as a precautionary measure due out of specification result for pH that was identified during routine stability testing.
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Atnahs Pharma UK Limited have identified missing information on the PIL of the above batches.
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Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets.
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Antibiotice SA have identified an error on PIL of the above batches regarding the sodium content.
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Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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SANTEN Oy (trading as Santen UK Limited) are recalling the above batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.
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Error relating to the stated alcohol content for batches of Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL), supplied by McNeil Products Limited
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One batch is being recalled due to out of specification results due to a low bioassay result at the 24-month shelf life stability testing.
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Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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Intrapharm Laboratories Ltd are recalling the above batch of Mydrilate 0.5 % Eye Drops 5ml as a precautionary measure due to out of specification results for related substances obtained during stability testing.