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Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets.
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This alert has been issued as B. Braun Melsungen AG has informed us that during regular visual inspection of retained samples of Sodium Bicarbonate solutions with bromobutyl stoppers precipitation in solution was observed. …
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Mylan UK Healthcare Ltd has informed us that a product complaint has been received relating to crystalline precipitate being observed during bottle use. Due to concerns with continuity of supply these batches are not being r…
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Accord-UK Ltd is recalling the listed batches after retesting showed out of specification results.
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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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Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.
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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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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MHRA that the Patient Information Leaflet (PIL) packaged in certain batches of Zestoretic 20mg/12.5mg Tablets contains outdated safety information.
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Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contaminati…
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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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Fairmed Healthcare GmbH has informed us of a discrepancy on the product packaging for some batches. The discrepancy relates to the incorrect spelling of one of the active pharmaceutical ingredients printed on one side of the…
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Sun Pharma UK Limited is conducting a precautionary recall of a single batch of Fingolimod SUN 0.5 mg hard capsules due to reports of capsule breakage on removing from the blister. No other batches of Fingolimod SUN 0.5mg ha…
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Glenmark Pharmaceuticals Europe Ltd is recalling the affected batches as a precautionary measure due to out of specification results for unknown impurities during routine stability testing and additional re-testing.
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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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Syri Limited, T/A SyriMed is recalling this batch of product as a precautionary measure due to crystallisation observed over time in the oral solution.
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Glenmark Pharmaceuticals Europe Ltd is recalling this batch after retesting showed out of specification results.
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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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Immunocore Limited is recalling the batches listed below as a precautionary measure. The recall is due to a decrease in potency identified during stability testing. All other stability test results remain within specificatio…
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Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed for subcu…
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Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect.
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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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Norgine Limited is recalling one batch of product as a precautionary measure due to some units containing low amounts of active ingredients.
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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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Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…
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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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Grünenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall.
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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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The MHRA has notified Bausch and Lomb UK Limited of reports that Emerade pens have failed to activate. The MHRA is advising that Emerade devices should not be recalled.
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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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Sanofi is recalling specific batches of Largactil 50mg/2ml Solution for Injection as a precautionary measure due to out of specification results obtained for the impurity chlorpromazine sulphoxide
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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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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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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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Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effect…
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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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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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The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.
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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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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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Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) in the listed batches of Cozaar 100mg film-coated tablets.
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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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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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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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…(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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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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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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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…