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…Takeda UK Ltd is recalling a specific batch of Vitaros 3mg/g cream 4 x 100mg.…
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Theramex Ireland Ltd T/A Theramex HQ UK Ltd has informed us that when decommissioning at the pharmacy and when scanning the serialised 2D code, the status of certain packs of AlfaD capsules may report as ‘EXPORT’
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Sanofi are recalling the listed batches of Taxotere (Docetaxel) Concentrate due to a production fault potentially leading to an increase in the concentration of Docetaxel in the solution.
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The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic…
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Theramex Ireland Ltd T/A Theramex HQ UK Ltd has informed us of an issue related to error in the decommissioning of a further batch. Upon decommissioning at the pharmacy and when scanning the serialised 2D code, the status of…
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Summary of the latest safety advice for medicines and medical device users
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The MHRA has made further changes to the way we issue safety messaging to healthcare providers.
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Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.
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(Gilead Sciences Limited) Pharmacists should quarantine any remaining stocks affected batches and return them to the original wholesaler for credi - class 2 action within 48 hours. (EL (14)A/03)
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Summary of the latest safety advice for medicines and medical device users
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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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(Morningside Healthcare Limited) Small number of blisters containing Buprenorphine 8mg Sublingual Tablets packed in cartons labelled Natzon 0.4mg Sublingual Tablets – class 2 action within 48 hours. (EL (13)A/23)
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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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(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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(Penn Pharma, distributed in Quantum Pharmaceutical livery) May result in evaporation of aqueous component of product and increase in concentration of Midazolam. (EL (14)/A10)
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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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(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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(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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(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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(Covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (MDA/2011/026)
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(Lincoln Medical Limited) Potential problem could result in a failure to deliver any adrenaline at all in an emergency situation – class 2 action within 48 hours. (EL (12)A/20)
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Following our latest review of medical device alerts, we have archived the ones listed below.
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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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(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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(Glaxo Wellcome UK Ltd) Source of possible contamination is believed to be sucrose used within this formulation of Questran – potential risk of glass fragments in bottles due to defect identified in very small number of bott…
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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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(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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(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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Summary of the latest safety advice for medicines and medical device users
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Summary of the latest safety advice for medicines and medical device users
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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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Summary of the latest safety advice for medicines and medical device users
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(Morningside Healthcare 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/24)
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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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(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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(Novartis Consumer Health UK Ltd) Fault with tamper seal on might result in small pieces of plastic being found in medicine. Class 2 action within 48 hours (EL (13)A/30)
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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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(Reckitt Benckiser Healthcare (UK) Limited) Remaining stock of batches should be quarantined and returned to original supplier for credit. - class 2 action within 48 hours. (EL (14)A/08)
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(Eli Lilly Nederland B.V.) 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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Following our latest review of medical device alerts, we have archived the ones listed below.
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(Bayer Consumer Care Division) Two batches inadvertently placed on the market containing patient information leaflet (PIL) for prescription only medicine (POM) product - class 4 caution in use. (EL(11)A/17)
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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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(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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Crescent Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of simvastatin 10 mg Tablets distributed by Alliance Healthcare UK.
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(Merck Sharp & Dohme Ltd) Study showed failure to reduce major vascular events and increase in non-fatal serious adverse events – class 2 action within 48 hours. (EL (13)A/02)
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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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(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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(Novartis Consumer Health UK Limited and Actavis Group PTC EHF): Product reclassified from P to POM due to safety concerns – class 2 action within 48 hours (EL (15)A/01)
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(Mylan) Carton incorrectly states "For children 2 to 5 years" but patient information leaflet (PIL) correctly states "For children 6 to 14 years" – class 2 action within 48 hours. (EL (13)A/08)
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(Sanofi Pasteur MSD) Some batches may have antigen levels below required specification – class 2 action within 38 hours. (EL (12)A/33)