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Class 4 Medicines Defect Information: Fresenius Kabi Limited, Kabiven Emulsion for Infusion, EL (22)A/02
Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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Field Safety Notices: 17 to 21 January 2022
List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 January 2022.
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Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited) IKERVIS 1 mg/mL eye drops, emulsion , EL (22)A/01
SANTEN Oy (trading as Santen UK Limited) are recalling the above batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.
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Field Safety Notices: 10 to 14 January 2022
List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 January 2022.
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Field Safety Notices: 3 to 7 January 2022
List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 January 2022
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Field Safety Notices: 29 to 31 December 2021
List of field safety notices (FSNs) from medical device manufacturers from 29 to 31 December 2021
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Company led medicines recall: Dermaved Sensitive Cream (unlicensed medicine), CLMR (21)A/09
Dermaved is recalling the above product from patients due to presence of clobetasol propionate (0.001% w/w).
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Field Safety Notices: 20 to 24 December 2021
List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 December 2021
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Class 4 Medicines defect information: Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL), EL(21)A/39
Error relating to the stated alcohol content for batches of Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL), supplied by McNeil Products Limited
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Rheovalves disposable needle-free valves: stop using specific lots due to risk of breakage in patient. DSI/2021/010
Baihe Medical have identified an increase in complaints for Rheovalves disposable needle-free valves product code RVNF1. Devices from specific lots are affected. There is a risk of the device breaking in use.
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Field Safety Notices: 13 to 17 December 2021
List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 December 2021
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Class 2 Medicines Recall: Wockhardt UK Ltd, Heparin sodium 1,000 I.U./ml solution for injection or concentrate for solution for infusion, EL (21)A/38
One batch is being recalled due to out of specification results due to a low bioassay result at the 24-month shelf life stability testing.
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Class 4 Medicines Defect Information: SmofKabiven Central emulsion for Infusion, Fresenius Kabi Ltd, EL (21)A/37
Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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Field Safety Notices: 6 to 10 December 2021
List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 December 2021
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Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Lucentis 10 mg/ml solution for injection in pre-filled syringe EL (21)A/36
Novartis Pharmaceuticals UK are recalling the above batch due to a faulty plunger stopper which has led to an increased number of customer complaints relating to the plunger being difficult to press down. The faulty plunger …
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Class 2 Medicines Recall: Intrapharm Laboratories Ltd, Mydrilate 0.5% Eye Drops 5ml, EL (21)A/35
Intrapharm Laboratories Ltd are recalling the above batch of Mydrilate 0.5 % Eye Drops 5ml as a precautionary measure due to out of specification results for related substances obtained during stability testing.
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Field Safety Notices: 29 November to 3 December 2021
List of field safety notices (FSNs) from medical device manufacturers from 29 November to 3 December 2021
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Medical device alerts archived in December 2021
Following our latest review of medical device alerts, we have archived the ones listed below.
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Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL(21)A/34
Specific batches of products supplied by Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.
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Field Safety Notices: 22 to 26 November 2021
List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 November 2021
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Class 4 Medicines Defect Information: Mometasone Furoate 50 Microgram / Dose Nasal Spray, Suspension, PilsCo Ltd, EL (21)A/33
Error relating to the wording on the outer carton label for Mometasone Furoate 50 Microgram / Dose Nasal Spray, supplied by PilsCo Ltd.
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Class 4 Medicines Defect Information: Diuril Oral Solution (unlicensed medicine), Mawdsley-Brooks & Company Limited, EL (21)A/32
Error with the patient information leaflet (PIL) that has been provided with Diuril Oral Solution, supplied by Mawdsley-Brooks & Company Limited.
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Field Safety Notices: 15 to 19 November 2021
List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 November 2021
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Handpieces used in the phacoemulsification technique of cataract removal: need for careful cleaning (DSI/2021/009)
Residue particles can end up in the patient’s eye.
For the attention of decontamination specialists, theatre practitioners and anyone involved with the cleaning and decontamination of medical devices.
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Class 3 Medicines Recall: Martindale Pharma, an Ethypharm Group Company Methadone 5mg Tablets / Physeptone 5mg Tablets, EL (21)A/31
Martindale Pharma is recalling the below batch of Methadone 5mg tablets as a precautionary measure due to the discolouration of the PVdC film in a small number of blister pockets.
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Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited) and parallel distributor, IKERVIS 1 mg/mL eye drops, emulsion and VERKAZIA 1 mg/mL eye drops, emulsion, EL (21)A/30
SANTEN Oy (trading as Santen UK Limited) are recalling the above batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.
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Company led medicines recall: Dotarem solution for injection (10ml Vial) - PL 12308/0016
Guerbet Laboratories Ltd is recalling the above batches of Dotarem 10ml vials due to the potential risk of a sterility break.
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Field Safety Notices: 8 to 12 November 2021
List of field safety notices (FSNs) from medical device manufacturers from Field Safety Notices: 8 to 12 November 2021
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Class 4 Medicines Defect Information: Slenyto 1 mg and 5mg prolonged-release tablets – distributed by Flynn Pharma Ltd, EL (21)A/29
Flynn Pharma Ltd, distributors of Slenyto 1 mg and 5mg prolonged release tablets would like to notify you of an error with the patient information leaflets (PILs) that have been packaged in the below batches of products.
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Class 2 Medicines Recall: Cold & Flu Relief Capsules (GSL) – Various Liveries, Wrafton Laboratories Limited (trading as Perrigo), EL (21)A/28
Perrigo are recalling the above batches of Cold & Flu Relief Capsules (GSL) – Various Liveries, due to an error on the leaflet and carton for the products as noted below.
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Medical device alerts archived in November 2021
Following our latest review of medical device alerts, we have archived the ones listed below.
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Field Safety Notices: 1 to 5 November 2021
List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 November 2021
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Class 4 Medicines Defect Information: Vygoris Limited, Mitocin (mitomycin) 20mg powder for solution for injection/infusion or intravesical use, EL (21)A/27
Vygoris Limited has informed the MHRA that some vials of Mitocin 20mg powder for solution for injection/infusion or intravesical use may contain subvisible particles above the current specifications after reconstitution…
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UPDATE: Class 4 Medicines Defect Information: Crescent Pharma Ltd, SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system, EL (20)A/36
Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the below batches are missing important safety relevant text changes.
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Field Safety Notices: 25 to 29 October 2021
List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 October 2021
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Class 3 Medicines Recall: Bimatoprost Aspire 0.3mg/ml eye drops, solution in single-dose container, Aspire Pharma Limited, EL (21)A/26
Aspire Pharma Limited is recalling the below batches of Bimatoprost Aspire 0.3mg/ml eye drops, solution in single dose container 0.4ml x 30 as a precautionary measure.
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Field Safety Notices: 18 to 22 October 2021
List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 October 2021
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Company led medicines recall: Irinotecan 200mg/ 260mL in sodium chloride 0.9% w/v intravenous infusion and Infliximab (Remsima) intravenous infusion in sodium chloride 0.9%
Qualasept Ltd t/a Bath ASU is recalling a specific batch of Irinotecan 200mg/260mL in sodium chloride 0.9% w/v intravenous infusion and specific batches of Infliximab (Remsima) Intravenous infusion in Sodium C…
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Field Safety Notices: 11 to 15 October 2021
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 October 2021
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Class 2 Medicines Recall: Pfizer Ltd, Champix (all strengths) film-coated tablets, EL (21)A/25
Pfizer Ltd are recalling all in-date batches of Champix (varenicline) as a precautionary measure due to presence of levels of N-nitroso-varenicline above the acceptable level of intake. This recall also includes Parallel Imp…
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Class 2 Medicines Recall: Tesco Flu-Max All In One Chesty Cough & Cold Powder for Oral Solution Wrafton Laboratoires Limited (trading as Perrigo) EL (21)A/24
Perrigo are recalling batches of Tesco Flu-Max All In One Chesty Cough & Cold Powder due to an error on the sachet contained within the outer carton.
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Field Safety Notices: 04 to 08 October 2021
List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 October 2021
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Medical device alerts archived in October 2021
Following our latest review of medical device alerts, we have archived the ones listed below.
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Field Safety Notices: 27 September to 01 October 2021
List of field safety notices (FSNs) from medical device manufacturers from 27 September to 01 October 2021
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Company led medicines recall: Glucose 10%w/v 10ml injection (unlicensed medicine) and Trometamol 7%w/v injection 5mL (unlicensed medicine)
East Suffolk and North Essex NHS Foundation Trust (MS 12882) is recalling specific batches of Glucose 10%w/v injection 10mL and Trometamol 7%w/v injection 5mL due to limited assurance of product sterility.
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Field Safety Notices: 20 to 24 September 2021
List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 September 2021
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Class 2 Medicines Recall: Accord-UK Ltd (Trading style: NorthStar), LEVOTHYROXINE TABLETS BP 50 micrograms EL (21)A/23
Accord-UK Ltd (Trading style: NorthStar) are recalling the above batch of product as a precautionary measure due to tablet hardness failures, leading to crumbling and breaking tablets.
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Field Safety Notices: 13 to 17 September 2021
List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 September 2021
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Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited), IKERVIS 1 mg/mL eye drops, emulsion, EL (21)A/22
SANTEN Oy (trading as Santen UK Limited) are recalling two batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.
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Field Safety Notices: 6 to 10 September 2021
List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 September 2021