-
Field Safety Notices: 16 to 20 May 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 May 2022.
-
Class 4 Medicines Defect Information: GlaxoSmithKline UK Ltd, Zovirax I.V. 500 mg, EL (22)A/22
GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.
-
Class 2 Medicines Recall: Quadrant Pharmaceuticals Ltd, Mefenamic Acid 500mg film coated tablets, EL (22)A/23
Quadrant Pharmaceuticals Ltd are recalling a specific batch of Mefenamic Acid 500mg Film-Coated Tablets as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the t…
-
Field Safety Notices: 09 to 13 May 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 May 2022
-
Field Safety Notices: 02 to 06 May 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 May 2022
-
Class 2 Medicines Recall: Pfizer Limited, Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets, EL(22)A/21
Pfizer Limited are recalling all batches of Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets as a precautionary measure
-
Field Safety Notices: 25 to 29 April 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 April 2022
-
Class 2 Medicines Recall: Fresenius Kabi Limited, Sodium bicarbonate 1.26% Solution for infusion, EL(22)A/20
Fresenius Kabi Limited are recalling a specific batch of product as a precautionary measure due to the identification of particles in the solution for injection, following routine batch analysis and subsequent batches manufa…
-
Class 2 Medicines Recall: Crescent Pharma Limited, Paroxetine 40mg Film Coated Tablets, EL(22)A/19
Crescent Pharma Limited are recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure.
-
Field Safety Notices: 18 to 22 April 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 April 2022
-
Class 4 Medicines Defect Information: Pfizer Limited, Depo-Medrone with Lidocaine 40 mg/mL (1 mL and 2 mL vials – single vial preparations), EL (22)A/18
Pfizer Limited have informed the MHRA that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the specific batches mentioned in this notification.
-
Field Safety Notices: 11 to 15 April 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 April 2022
-
Field Safety Notices: 4 to 8 April 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 April 2022
-
Class 2 Medicines Recall: USV UK Limited, Olopatadine USV 1mg/ml Eye Drops, Solution, EL(22)A/17
USV UK Limited are recalling specific batches of products as a precautionary measure due to out of specification results for impurities during routine stability testing.
-
Paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs): Updated position on use in patients with critical limb ischaemia and intermittent claudication DSI/2022/003
The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia.
-
Field Safety Notices: 28 March to 1 April 2022
List of field safety notices (FSNs) from medical device manufacturers from 28 March to 1 April 2022.
-
National Patient Safety Alert: Philips Health Systems V60, V60 Plus and V680 ventilators: potential unexpected shutdown leading to complete loss of ventilation (NatPSA/2022/002/MHRA)
Philips Health Systems informed have identified an important safety issue due to potential unexpected shutdowns of all of their V60 and V60 Plus non-invasive ventilators. All V680 invasive ventilators used in critical care …
-
Field Safety Notices: 21 to 25 March 2022
List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 March 2022.
-
Class 2 Medicines Recall: Pfizer Limited, Accuretic 10/12.5 mg film-coated tablets, EL (22)A/16
Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.
-
Field Safety Notices: 14 to 18 March 2022
List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 March 2022.
-
Class 4 Medicines Defect Information: Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder and solvent for suspension for injection, EL (22)A/15
Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack.
-
Company led medicines recall: Advanced Accelerator Applications NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) [unlicensed medicine], CLMR (22)A/02
Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during stability testing.
-
Field Safety Notices: 7 to 11 March 2022
List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 March 2022.
-
Class 4 Medicines Defect Information, Ayrton Saunders Limited, Beclometasone dipropionate 50 micrograms/dose Nasal Spray (Various Liveries), EL (22)A/14
Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.
-
Class 4 Medicines Defect Information: CNX Therapeutics Ltd, Latuda film-coated tablets, EL (22)A/13
CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on the cartons.
-
Class 4 Medicines Defect Information: Boots Company Plc, Decongestant Tablets and Decongestant with Pain Relief Tablets, EL (22)A/12
Boots have identified an error with the printed patient information leaflet provided with batches of the Decongestant Tablets and Decongestant with Pain Relief Tablets.
-
Field Safety Notices: 28 February to 4 March 2022
List of field safety notices (FSNs) from medical device manufacturers from 28 February to 4 March 2022.
-
Class 2 Medicines Recall: Wockhardt UK Ltd, Diazepam RecTubes 2.5mg Rectal Solution, EL (22)A/11
Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability testing.
-
Field Safety Notices: 21 to 25 February 2022
List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 February 2022.
-
Class 3 Medicines Recall: Kyowa Kirin Services Ltd. Isotard 60mg XL Tablets, EL (22)A/10
Kyowa Kirin Services Ltd. are recalling a batch of Isotard 60mg XL Tablets as a precautionary measure due to microfibres/crystals of the Active Pharmaceutical Ingredient (API) being present on the surface of the tablets…
-
UPDATE: Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, Naprosyn EC 500mg Gastro-Resistant Tablets, EL (22)A/09
Atnahs Pharma UK Limited have identified additional missing information on the PIL of the certain product batches.
-
Field Safety Notices: 14 to 18 February 2022
List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 February 2022.
-
Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Fluorouracil Injection, 50 mg/ml, solution for injection (2500mg/50ml vial), EL (22)A 08
medac GmbH (t/a medac Pharma LLP) are recalling certain product batches as a precautionary measure due to visual detection of glass lamellae particles during an ongoing stability study.
-
Surdial X Haemodialysis machine: potential for devices to remove excess fluid outside of machine specification. DSI/2022/002
The MHRA are aware of instances of Surdial X machines removing excess fluid via ultrafiltration outside of its specification. There is a risk to patients who are unable to tolerate excess fluid removal.
-
Stop using Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK: all lots and batches. DSI/2022/001
The MHRA has become aware that Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK are being sold with a falsely applied CE mark. This means that these devices have been sold wit…
-
Class 2 Medicines Recall: Uni Health Distribution, Efudix 5% w/w cream, EL (22)A 07
Uni Health Distribution is aware of a potential issue where the leaflet contained within Efudix 5% w/w cream (2 x 20g) pack, batch 80193439/B may be incorrect.
-
Field Safety Notices: 7 to 11 February 2022
List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 February 2022.
-
Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A 06
hameln pharma ltd is recalling a batch of a product as a precautionary measure as remaining vials may no longer be in line with the licensed product specification
-
Company led medicines recall: Bucain Hyperbar 5mg/ml Solution for Injection (unlicensed medicine), CLMR (22)A/01
Mawdsley-Brooks & Company Limited (UK importer) is recalling a specific batch of this product as a precautionary measure due out of specification result for pH that was identified during routine stability testing.
-
Field Safety Notices: 31 January to 4 February 2022
List of field safety notices (FSNs) from medical device manufacturers from 31 January to 4 February 2022.
-
Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, EL (22)A/05
Atnahs Pharma UK Limited have identified missing information on the PIL of the above batches.
-
Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, EL (22)A/04
Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets.
-
Field Safety Notices: 24 to 28 January 2022
List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 January 2022.
-
Class 4 Medicines Defect Information: Antibiotice SA, Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion, EL (22)A/03
Antibiotice SA have identified an error on PIL of the above batches regarding the sodium content.
-
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.
-
Field Safety Notices: 17 to 21 January 2022
List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 January 2022.
-
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.
-
Field Safety Notices: 10 to 14 January 2022
List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 January 2022.
-
Field Safety Notices: 3 to 7 January 2022
List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 January 2022
-
Field Safety Notices: 29 to 31 December 2021
List of field safety notices (FSNs) from medical device manufacturers from 29 to 31 December 2021