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Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply chain due to a ware…
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Sun Pharmaceutical Industries Europe B.V. is recalling those product batches listed in this notification as a precautionary measure due to out of specification results reported for the Particulate Matter Test (PMT) during st…
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Accord Healthcare Ltd is recalling various 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 content…
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Atnahs Pharma UK Limited have identified missing information on the PIL of the above batches.
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
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medac GmbH (t/a medac Pharma LLP) is recalling further batches due to particles detected during long-term stability tests.
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Perrigo are recalling batches of Tesco Flu-Max All In One Chesty Cough & Cold Powder due to an error on the sachet contained within the outer carton.
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Perrigo are recalling the above batches of Cold & Flu Relief Capsules (GSL) – Various Liveries, due to an error on the leaflet and carton for the products as noted below.
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Atnahs Pharma UK Ltd has informed the MHRA that the batches of Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension listed in this notification do not contain the most up to date safety information.
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Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the below batches are missing important safety relevant text changes.
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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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Further to previous recalls of Valsartan and Irbesartan containing products, which were potentially contaminated with N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA), we have become aware of products containing…
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…(Auden Mckenzie Ltd) Small number may contain 3 blister strips –class 4 caution in use. (EL (13)A/05)…
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Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles.
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Morningside Healthcare Limited has informed the MHRA of a packaging issue identified in batch MRA2303 of Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules and batch MRF2301 of Tramadol Hydrochloride 50 mg C…
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Ferring Pharmaceuticals Limited is recalling all unexpired stock of the products below from pharmacies and wholesalers as a precautionary measure due to a lower volume of solution being observed in the bottles, and out of sp…
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medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified in this notification due to particles detected during long-term stability tests.
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Glenmark Pharmaceuticals Europe Ltd is recalling various batches after retesting showed out of specification results.
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Specific batches of products supplied by Bristol Laboratories Limited, Brown & Burk UK Limited and Teva UK Limited are being recalled due to presence of a mutagenic impurity.
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…(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)…
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…(Lundbeck Limited) Reports of cracked ampoules and concerns about guaranteeing sterility – class 2 actions within 48 hours (EL (11)A/33)…
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…(Teva UK Limited) Damaged vials so potential for a lack of sterility assurance - class 2 action within 48 hours. (EL (13)A/31)…
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Accord Healthcare limited is recalling a single batch due to an out of specification test result.
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Sun Pharma UK Ltd is recalling certain batches as a precautionary measure due to a small number of leaks found intermittently in the infusion bags.
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Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information.
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Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’ text was added to the carton in December 2008 in error.
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…(Accord Healthcare Limited) Recipients should quarantine any remaining stock and return it to supplier for credit - class 2 action within 48 hours. (EL (13)A/32)…
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Lupin Healthcare (UK) Limited has informed us of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets. This discrepancy relates to …
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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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…(Pfizer Limited) Clarification of confusion resulting from amended labels and patient information leaflet – class 4 caution in use. (EL (12)A/31)…
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…(Teva UK and Numark liveries) Remaining stock should be returned to wholesaler for credit – class 3 action within 5 days. (EL (12)A/13)…
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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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(Novartis Pharmaceuticals UK) Increased risk of malignancies with long -term use of calcitonin – class 2 action within 48 hours. (EL 13(A)11)
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…(Pfizer Limited) Very small number of ampoules containing glass particles identified – class 3 action within 5 days. (EL (13)A/14)…
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…(ITH Pharma Ltd) Remaining stocks should be quarantined and returned to original supplier for credit - class 2 action within 48 hours. (EL (14)A/06)…
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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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…(Novartis Vaccines and Diagnostics GmbH) Potential problem with packaging of the syringes supplied with specific batches of Rabipur – class 4 caution in use. (EL (12)A/13)…
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…(Lundbeck Limited) May result in suboptimal dosage of the product - class 2 action within 48 hours. (EL (14)A/19)…
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…(McNeil Products Limited) Remaining stocks of the above products should be quarantined - class 2 action within 48 hours. (EL (14)A/14)…
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…(Eli Lilly) Recall following clinical trial findings showing lack of efficacy and risk/benefit concerns – class 1 action now. (EL (14)A/15)…
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Sanofi UK is recalling the listed batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of manufacturer for vigabatrin.
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…(ratiopharm GmbH) Corrected batch numbers from EL (13)A/04 –class 3 action within 5 days. (EL (13)A/04 Rev 1)…
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Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK.
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…(Gilead Sciences International Limited) Remaining stocks of affected batches should be quarantined and returned to the original supplier for credit – class 1 action now. (EL (13)A/17)…
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
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…(GlaxoSmithKline UK) Remaining stocks of the affected batch should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/26)…
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…(Sanofi-aventis) Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/07)…
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…(Wockhardt UK Ltd) Remaining stock from affected batches should be quarantined and returned to the original supplier for credit - class 2 action within 48 hours. (EL (14)A/11)…
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…(Actavis UK Ltd) Use of incorrect blister foil which fails to meet the specification for child resistancen – class 2 action within 48 hours. (EL (12)A/24)…
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…(Reckitt Benckiser Healthcare (UK) Limited) Remaining stock should be quarantined and returned to original supplier for credit - class 2 action within 48 hours. (EL (14)A/04)…