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Pfizer UK Limited is recalling batches as routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.
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…(Santen UK Ltd) Two batches of Ikervis 1 mg/ml eye drops, emulsion (30 single dose containers) (ciclosporin), are being recalled because micro particles of the active ingredient were found in stability test samples (EL(16)A/07)…
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…(Teva UK Limited) Precautionary batch recall of Evacal D3 1500mg/400iu Chewable Tablets after metal contamination was identified in a very small number of tablets…
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…Baxter Healthcare Limited are initiating a precautionary, company-led, ward-level recall of two batches of Sodium Chloride Infusion 0.9% w/v 1000 mL bags due to a potential leak with the bags.…
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Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of the pre-filled syringe and tubing catheter.…
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…Due to concerns with continuity of supply these batches are not being recalled at this time.
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As a precautionary measure, Pfizer Limited is recalling the above batches from wholesalers due to out of specification results from the ongoing stability studies.…
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…(Lipomatrix Inc) conclusions of research after device was recalled for risks of break down of filler and update of HN2000(05). (MDA/2004/047)…
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Manufactured by Synthes GmbH - Recall of Radial Head Prosthesis System. Associated Radial Head Prosthesis system parts also need to be returned to DePuy Synthes but will be available for revision surgeries of the radial head component.
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The MHRA has re-issued this notification as Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the notification.…
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Manufactured by Synthes GmbH – Recall due to risk of infection from cracked weld of the handle.
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Accord-UK Ltd has informed us of an issue related to decommissioning of the batch below.
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Accord-UK Ltd has informed us of an issue related to decommissioning of a specific batch
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Manufactured by Intersurgical, used in devices made by other companies: cracks in swivel elbow connectors may lead to prescribed ventilation not being delivered.
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…Takeda UK Ltd is recalling a specific batch of Vitaros 3mg/g cream 4 x 100mg.…
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Blumont Pharma Limited is reporting to the MHRA regarding the absence of Braille on the outer carton of one batch of Ocumont Eye Ointment 1% w/w (POM). It was identified that the Braille information was inadvertently omitted…
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Viatris has received reports of brown discolouration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to oxidation of the syringe needle.
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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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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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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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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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(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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(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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Summary of the latest safety advice for medicines and medical device users
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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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(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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(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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(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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(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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(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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(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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(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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(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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(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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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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(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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(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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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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Summary of the latest safety advice for medicines and medical device users
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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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(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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(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)