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IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date.
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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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Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February – 02 March 2018
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Manufactured by AFP Medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (MDA/2018/008).
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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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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 27 November to 1 December 2017.
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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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Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
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Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
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Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - MDA/2015/038
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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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(Medtronic) Risk due to incorrect selection and delivery of bolus amount. (MDA/2014/019)
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(Roche Diagnostics Ltd) Increased risk that the vibration alarm will not work as a result of a changed component. (MDA/2014/008)
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(Patterson Medical) May cause the user to fall. (MDA/2013/060)
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(Medtronic) May lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). (MDA/2013/035)
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(Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)
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(All manufacturers) foam heads of oral swabs may detach from the stick during use, which may present a choking hazard for patients. (MDA/2012/020)
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(All types of bed mattresses) body or other fluids can pass through and contaminate inner core of damaged mattresses or covers and cause cross-infection if used. (MDA/2010/002)
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(Medtronic) error in the programmer software (revision NNB_01) which may lead to false warnings of a low battery status. (MDA/2008/065)
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(All) MHRA continues to receive adverse incident reports of patient hoists and slings used in hospitals and the community that have resulted in serious patient injury or fatalities. (MDA/2007/031)
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(All) risk of pneumococcal meningitis in cochlear implant patients. (MDA/2006/019)
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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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(Medtronic) diamorphine solution is incompatible with the implantable drug pump. (MDA/2003/035)