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Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)
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FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)
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Caution in Use: Distribute to Pharmacy and Clinic Level.
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Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
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Glaxo Wellcome UK Limited is recalling one lot of Seretide Accuhaler 50/250mcg because a manufacturing issue has resulted in a small number of units not delivering the full number of doses. (EL (18) A/04)
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Glaxo Wellcome UK is recalling two Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses (EL…
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Manufactured by ICU Medical (formerly Hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (MDA/2018/006).
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Bayer plc and GE Healthcare AS are recalling batches of Magnevist Solution for injection, 0.5mmol/ml, intravenous and Omniscan Solutions for injection 0.5 mmol/ml following a safety review of the gadolinium containing contra…
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The supply of batteries for these devices has been temporarily stopped so there may be a significant delay in the fulfillment of orders for new batteries.
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Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.
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Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
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Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.
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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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Torrent Pharma (UK) Ltd is recalling the below batches as a precaution because out of specification results for dissolution were obtained during routine stability testing.
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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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Pharmacy and wholesaler level recall of two batches of Parallel Imported One-Alpha Drops x 10 ml because the dropper included in this pack delivers 0.05 micrograms of alfacalcidol instead of 0.1 micrograms as labelled on the…
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MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018)
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Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.
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Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
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[Archived] (Smith & Nephew Orthopaedics) Birmingham Hip™ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups (MDA/2015/024)
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(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)
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(Hospira) Use an alternative pump, where available. (MDA/2013/078)
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(Philips) Motorised geometry control system will reboot if users attempt simultaneous powered and manual movement of the C-arm. (MDA/2013/045R)
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(Philips) Table will reboot if users attempt a powered and manual movement at the same time. (MDA/2013/045)
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(All models and manufacturers) Be aware of the various maximum implant durations for safe retrieval for each IVC filter model. (MDA/2013/028)
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(Hospira) Due to pump faults. (MDA/2013/016)
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[Archived] (Finsbury Orthopaedics Ltd) Do not implant ADEPT® 12/14 modular head devices. (MDA/2013/010)
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(Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)
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[Archived] (All) MHRA issues updated information and advice for the follow-ups of patients implanted with metal-on-metal (MoM) hip replacements. (MDA/2012/036)
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(Q-Med AB - a Galderma division) problem with use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation which can make diagnosis of breast cancer more difficult. (MDA/2012/022)
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(All) uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma (ALCL) of the breast - none reported in the UK. (MDA/2011/017)