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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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Takeda UK Ltd are issuing a company-led drug alert for one batch of Calcichew-D3 500mg/400 IU Caplets due to traces of a non-approved excipient (CLDA (17)A/05)
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Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
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Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre 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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FDC International Ltd is recalling the batches listed below as a precautionary measure due to a precipitate observed in the bottles.
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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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Bayer plc has informed us that they have received two complaints globally concerning Mirena inserters with an insertion tube which is mounted inversely to the handle
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Sanofi has informed us that there is an error in the Braille on some batches of Arava 10mg film-coated tablets (EL (17)A/01)
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Medreich has provided handling instructions following several complaints that the child-resistant caps are difficult to open (EL(16)A/17)
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Sanofi is recalling the A5545 batch of Rifadin because an investigation of out of trend results indicated that it was contaminated with chilled water circulating in the jacket of the reactor during manufacture. (EL(16)A/04)
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Potentially a rogue blister and carton may be present in a batch of Crestor 5mg Tablets Parallel Imported by BR Lewis Pharmaceuticals Ltd (Originator name Provisacor) – Class 4 Caution in Use. (EL (16)A/03)
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Action within 48 hours: patient, pharmacy and retail level recall of St John's Wort tablets. Testing has shown the presence of a toxic pyrrolizidine alkaloid (PA) above the threshold recommended by the Committee on Herba…
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Specific batch distributed by Sandoz Ltd is being recalled due to particulate matter found in samples.
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(Zentiva) Pharmacists should quarantine remaining stock and return to original wholesaler (EL (15)A/13)
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(Laboratoire SERB) EAN barcode is incorrect – when scanned, it identifies the product as Primidone SERB 250mg tablets not 50mg tablets (EL (15)A/10)
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(AstraZeneca UK Limited) This presentation cannot be administered by intra-articular means as it states on the carton and ampoule label on all batches released since December 2012 (EL(15)A/09)
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(Allergan Limited) Small number of complaints have been received about small black particles found on or around the nozzle of the tube (EL (15)A/08).
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(Teva UK Limited) 25mg has been incorrectly printed in one position of the affected foil packs however is correct in other positions (EL(15)A/07).
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(Uab Norameda) distributor Peckforton Pharmaceuticals Limited has identified an error on the presentation of the 50ml carton - the coloured band on the package should be purple not pink although text is correct (EL(15)A/06).
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(Generics (UK) Limited, trading as Mylan UK) A small number of packs from a specific batch may have an over count or under count of one tablet (EL (15)A/05).
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(RelonChem Ltd/ Kent Pharmaceuticals) All unexpired batches of 50mg Tramadol capsules are being recalled due to the risk of fungal contamination. Class 2 – action within 48 hours. (EL (15)A/04)
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(Allergan UK Limited) Specific batch including a Danish language pack was shipped to the UK in error. Class 3 – action within 5 days. (EL (15)A/03)
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(Aventis Pharma Limited and Winthrop Pharmaceuticals UK Limited) The smell associated with some batches is said to be a result of the foil packaging, but patients should continue taking their medicine. (EL (15)A/02)
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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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(GlaxoSmithKline) Check each vial for cracks by turning upside down and looking for chips, cracks or damage where base meets side wall. (EL (14)A/15)
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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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(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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(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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(ViroPharma SPRL) Pharmacists should quarantine batches and return them to original wholesaler for credit - class 2 action within 48 hours. (EL (14)A/12)
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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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(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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(Wockhardt UK Ltd) Should not be used in neonates and infants under 1 year old until further notice. (EL (14)A/09)
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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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(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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(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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(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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(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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(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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(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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(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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(Teva UK Ltd) Leaflet incorrectly states take 1 or 2 tablets a day. (EL (14)A/01)
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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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(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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(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)