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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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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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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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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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Accord Healthcare limited is recalling a single batch due to an out of specification test result.
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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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…(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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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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…(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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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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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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…(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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…(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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(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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…(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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Eaststone Limited is initiating a recall of all batches of quetiapine oral suspension products due to a potential risk of overdose, which could have consequences for the safety of patients.
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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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…(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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…(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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…(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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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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…(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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…(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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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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…(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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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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…(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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…(Mylan on behalf of Strides Arcolab International Limited) Remaining stocks of affected batches should be quarantined - class 2 action within 48 hours. (EL (14)A/07)…
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…(Teva UK Limited) red precipitate found during stability testing under cold storage conditions - class 2 action within 48 hours. (EL (14)A/13)…
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…(Merck Sharp and Dohme) Increase in the number of adverse events and product complaints following introduction of ‘winged’ presentation - class 2 action within 48 hours. (EL (14)A/02)…
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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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…(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)…
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LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy.
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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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Atnahs Pharma UK Limited have identified additional missing information on the PIL of the certain product batches.
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…(Hospira UK Limited) Visually inspect vials for particulate matter prior to use and do not use if crystals are found - Class 4 medicines defect information (EL (13)A/09)…
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…(ITH Pharma Ltd) Small number of reported cases of bacillus cereus septicaemia affecting neonates - class 1 action now. (EL (14)A/05)…
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…(Pinewood Laboratories Limited) 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/18)…
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…- class 2 action within 48 hours. (EL (14)A/08)…
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…– class 2 action within 48 hours. (EL (13)A/24)…
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(Teva UK Limited) results of assays carried out during routine stability studies did not comply with the required specification – class 3 action within 5 days. (EL 13(A)11)
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…(Bristol-Myers Squibb Pharmaceuticals Limited) Source of possible contamination is believed to be sucrose used within this formulation of Questran – class 2 action within 48 hours. (EL (13)A/15)…
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…Remaining stocks of affected batch should be quarantined and returned to original supplier for credit – class 2 action within 48 hours. (EL (13)A/22)…
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Bells Healthcare is recalling the listed batches of dextromethorphan hydrobromide BP containing products as a precautionary measure, due to foreign material detected in some bottles.