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MHRA alerts & recalls

PharmData maintains a list of all MHRA alerts and recalls relevant to community pharmacy. Registered users can receive instant email notifications of new alerts, and record their responses to MHRA alerts within their PharmData account.

Title of alert Date of alert Date of response
Class 2 Medicines Recall: Aripiprazole 1mg/ml oral solution (EL (19)A/20) July 30, 2019, 11:00 am (19 day(s) ago) Log in to respond
FMD Alert: Class 2 (EL (19)A/19) July 25, 2019, 3:03 pm (23 day(s) ago) Log in to respond
Class 2 Medicines Recall: Bisacodyl 5mg Gastro-Resistant tablets batch 25074A (MDR 34-04/19) July 24, 2019, 12:00 pm (24 day(s) ago) Log in to respond
Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 55-06/18) July 11, 2019, 11:00 am (1 month(s) ago) Log in to respond
Class 4 Medicines Defect Information: Phenobarbital Sodium 30mg/ml Injection (MDR 48-02/19) July 8, 2019, 2:00 pm (1 month(s) ago) Log in to respond
FMD Alert: Class 2 (MDR 123-05/19) June 27, 2019, 3:36 pm (2 month(s) ago) Log in to respond
FMD Alert: Class 2 (EL (19)A/15) June 27, 2019, 3:36 pm (2 month(s) ago) Log in to respond
Class 2 Medicines Recall: Paracetamol 500mg Tablets, 1 x 1000 PL 04077/0001 (MDR 13-04/19) June 13, 2019, 11:03 am (2 month(s) ago) Log in to respond
Class 2 Medicines Recall: Co-amoxiclav 125 mg/31.25 mg/5 ml and 25 mg/62.5 mg/5 ml Powder for Oral Suspension (MDR 24-05/19) May 13, 2019, 11:01 am (3 month(s) ago) Log in to respond
Class 4 defect information: Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe. (MDR 18-01/19) February 18, 2019, 11:07 am (6 month(s) ago) Log in to respond
Class 2 Medicines recall: Actavis Group PTC EHF - Irbesartan 300mg Film-coated tablets, PL 30306/0108 and Irbesartan / Hydrochlorothiazide 300 / 25mg Film-coated Tablets, PL 30306/0267 (MDR 94-06/18) February 13, 2019, 10:59 am (6 month(s) ago) Log in to respond
Class 4 defect information: Amoxicillin 500mg Capsules BP (MDR 92-12/18) February 4, 2019, 2:01 pm (6 month(s) ago) Log in to respond
Class 2 Medicines Recall: Macleods Pharma UK Limited - Irbesartan 150mg Film-coated tablets, PL 34771/0079 (MDR 94-06/18) January 24, 2019, 12:14 pm (7 month(s) ago) Log in to respond
Class 2 Medicines Recall: Actavis Group PTC EHF - recall of batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets January 3, 2019, 12:30 pm (8 month(s) ago) Log in to respond
Class 2 Medicines Recall: Teva UK Limited and Mylan - recall of some Valsartan containing products November 30, 2018, 10:30 am (9 month(s) ago) Log in to respond
Class 4 defect information: Olmetec 20mg Film Coated Tablets (MDR 12-08/18) September 3, 2018, 11:01 am (12 month(s) ago) Log in to respond
Class 3 Medicines Recall: Sodium Cromoglicate eye drops and Murine Hayfever Relief eye drops (MDR 072-05/17) July 30, 2018, 3:01 pm (1 year(s) ago) Log in to respond
Melatonin 10mg capsules: Company-led recall July 17, 2018, 9:59 am (1 year(s) ago) Log in to respond
Class 4 medicines defect information: Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU PL 16508/0046 June 19, 2018, 11:05 am (1 year(s) ago) Log in to respond
Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension - company led recall May 16, 2018, 2:36 pm (1 year(s) ago) Log in to respond
Class 3 Medicines Recall: Latanoprost Timolol Eye drops May 2, 2018, 4:31 pm (1 year(s) ago) Log in to respond
Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07) April 18, 2018, 2:59 pm (1 year(s) ago) Log in to respond
Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib) March 12, 2018, 11:47 am (1 year(s) ago) Log in to respond
Class 4 Medicines Defect Information: Bleo-Kyowa, powder for solution for injection, 15,000 IU February 22, 2018, 2:00 pm (2 year(s) ago) Log in to respond
Class 2 Medicines Recall: Seretide Accuhaler 50 microgram/250 microgram/dose inhalation powder, pre-dispensed February 21, 2018, 3:59 pm (2 year(s) ago) Log in to respond
Class 2 Medicines Recall: Ventolin Accuhaler 200mcg (Salbutamol Sulfate) February 21, 2018, 3:52 pm (2 year(s) ago) Log in to respond
Class 2 Medicines Recall: Molipaxin 100 mg capsules (one batch) January 3, 2018, 2:35 pm (2 year(s) ago) Log in to respond
Class 4 Medicines Defect Information: Co-Amoxiclav 1000mg/200mg Powder for Solution (EL (17) A-14) December 19, 2017, 11:00 am (2 year(s) ago) Log in to respond
Class 4 Medicines Defect Information: BUCCOLAM (midazolam) Oromucosal Solution Pre-filled Syringes December 8, 2017, 12:04 pm (2 year(s) ago) Log in to respond
Calcichew-D3 500mg/400 IU Caplets - Pharmacy level recall November 29, 2017, 11:32 am (2 year(s) ago) Log in to respond
Class 4 medicines defect information: Kyowa Kirin Bleo-Kyowa® Powder for Solution for Injection 15,000 IU November 13, 2017, 4:55 pm (2 year(s) ago) Log in to respond
Class 4 medicines defect information: some batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API) October 17, 2017, 12:29 pm (2 year(s) ago) Log in to respond
Class 2 Medicines Recall: Xarelto 20 mg film-coated tablets (Rivaroxaban) September 28, 2017, 4:38 pm (2 year(s) ago) Log in to respond
Error with the barcodes on selected batches of 8 medicinal products by Focus Pharmaceuticals - Distribute to Pharmacy and Wholesaler level September 4, 2017, 11:30 am (2 year(s) ago) Log in to respond
Class 3 Medicines Recall: Specific batches of Torrent Dutor (Duloxetine) Gastro-resistant Capsules July 31, 2017, 11:30 am (2 year(s) ago) Log in to respond
Sodium Chloride Infusion 0.9% w/v 1000 mL bags July 13, 2017, 3:02 pm (2 year(s) ago) Log in to respond
Parallel Imported One-Alpha Drops x 10 ml - Pharmacy and wholesaler level recall of two batches June 30, 2017, 11:26 am (2 year(s) ago) Log in to respond
Class 2 Medicines Recall: Sodium Cromoglicate 2% w/v 13.5 mL Eye Drops May 19, 2017, 11:28 am (2 year(s) ago) Log in to respond
Class 4 Caution in Use : Mirena 20 micrograms / 24 hours intrauterine delivery system January 5, 2017, 2:32 pm (3 year(s) ago) Log in to respond
Class 4 Caution in Use: Arava 10mg film-coated tablets (Leflunomide) January 3, 2017, 2:30 pm (3 year(s) ago) Log in to respond
Class 4 Caution in Use: Amoxicillin Sugar Free Suspension 250mg/5ml & Amoxicillin Sugar Free Suspension 125mg/5ml December 14, 2016, 2:24 pm (3 year(s) ago) Log in to respond
Aventis Pharma Limited trading as Sanofi Rifadin 600mg Infusion May 6, 2016, 10:40 am (3 year(s) ago) Log in to respond
Crestor 5mg Tablets Parallel Imported by BR Lewis Pharmaceuticals Ltd (Originator name Provisacor) –rogue blister and carton April 28, 2016, 3:38 pm (3 year(s) ago) Log in to respond
Class 2 medicines recall: Asda, St John’s Wort, HRI Good Mood and Superdrug St John’s Wort tablets THR 02231/0002 February 8, 2016, 11:03 am (4 year(s) ago) Log in to respond
Fludarabine 25mg/ml, 1 x 2ml - EBEWE Pharma Ges.m.g.h (CLDA (15) A/13) December 18, 2015, 3:47 pm (4 year(s) ago) Log in to respond
Specific batches of Omeprazole 20mg gastro-resistant capsules (hard) - capsule shells may be more brittle than normal December 16, 2015, 11:32 am (4 year(s) ago) Log in to respond
Wockhardt UK Ltd - Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection November 10, 2015, 11:30 am (4 year(s) ago) Log in to respond
Primidone SERB 50mg tablets - error on the carton November 9, 2015, 2:40 pm (4 year(s) ago) Log in to respond
All batches of Marcain Polyamp Steripack 0.5% (bupivacaine hydrochloride) - error on carton and ampoule label about administration October 29, 2015, 3:47 pm (4 year(s) ago) Log in to respond
Lacri-Lube Eye Ointment - small black particles on or around the nozzle of the tube September 21, 2015, 3:29 pm (4 year(s) ago) Log in to respond
Pregabalin 75mg capsules - incorrect strength printed in one area of foil blister pack August 12, 2015, 11:44 am (4 year(s) ago) Log in to respond
Propofol 10mg/ml (1%) Emulsion for Injection/Infusion 50ml presentation - incorrect colour identifying volume on package July 16, 2015, 11:31 am (4 year(s) ago) Log in to respond
Xenidate XL 36mg prolonged-release tablets (methylphenidate hydrochloride) - incorrect number of tablets in packs from a specific batch June 29, 2015, 11:30 am (4 year(s) ago) Log in to respond
Tramadol 50mg capsules - risk of fungal contamination May 6, 2015, 11:41 am (4 year(s) ago) Log in to respond
Exocin 3mg/ml eye drops - recall of Danish language packs April 23, 2015, 12:06 pm (4 year(s) ago) Log in to respond
Defect with Epilim/ sodium valproate gastro-resistant tablets - some batches have an odour March 30, 2015, 12:24 pm (4 year(s) ago) Log in to respond
Oral diclofenac presentations with legal status ‘P’ – reclassified to POM January 14, 2015, 11:07 am (5 year(s) ago) Log in to respond
Amoxil Vials for injection 500mg and 1g, Augmentin Intravenous 600mg and 1.2g - cracks in vials used for packaging December 17, 2014, 3:05 pm (5 year(s) ago) Log in to respond
Motilium 10 10mg Tablets and Motilium Instants10mg – changed to prescription-only medicine December 17, 2014, 3:05 pm (5 year(s) ago) Log in to respond
Idarubicin 1mg/ml injection 5 & 10 ml - recall December 17, 2014, 3:04 pm (5 year(s) ago) Log in to respond
Buccolam Oromucosal Solution - possibility for chemical contamination December 17, 2014, 3:04 pm (5 year(s) ago) Log in to respond
Amoxicillin Sodium 500mg Powder for Solution for Injection - additional reports of injection site reactions in paediatrics and adults December 17, 2014, 3:04 pm (5 year(s) ago) Log in to respond
Midazolam Buccal Liquid 10mg / 1ml, 5ml - screw caps not been correctly placed December 17, 2014, 3:04 pm (5 year(s) ago) Log in to respond
Amoxicillin Sodium 250mg, 500g, & 1mg powder for solution for injection - reports of extravasation and injection site reactions December 17, 2014, 3:04 pm (5 year(s) ago) Log in to respond
Fybogel Hi-Fibre and Fybogel Orange - potential risk of contamination with metal particles December 17, 2014, 3:04 pm (5 year(s) ago) Log in to respond
Clarithromycin 500mg Powder for Solution for Infusion - small particles of white material to be present in individual vials December 17, 2014, 3:04 pm (5 year(s) ago) Log in to respond
Vancomycin Powder for Concentrate for Solution for Infusion - small particles of fibre material and glass in individual vials December 17, 2014, 3:04 pm (5 year(s) ago) Log in to respond
Lipid Phase only of Parenteral Nutrition - potential contamination with Bacillus cereus December 17, 2014, 3:04 pm (5 year(s) ago) Log in to respond
Fybogel Orange - risk of contamination with metal particles December 17, 2014, 3:03 pm (5 year(s) ago) Log in to respond
Viread 245 mg Film-Coated Tablets - possible presence of silicone rubber December 17, 2014, 3:03 pm (5 year(s) ago) Log in to respond
COSOPT preservative-free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container - difficulties with administration December 17, 2014, 3:03 pm (5 year(s) ago) Log in to respond
Irbesartan / Hydrochorothiazide Teva 300/12.5mg and 300/25mg film-coated tablets - incorrect dosing instruction in patient information leaflet December 17, 2014, 3:03 pm (5 year(s) ago) Log in to respond
Irbesartan 300mg film-coated tablets - blisters is incorrectly labelled as Irbesartan 150mg December 17, 2014, 3:03 pm (5 year(s) ago) Log in to respond
Methotrexate 25mg/ml Injection - damaged vials December 17, 2014, 3:02 pm (5 year(s) ago) Log in to respond
Tixylix® liquid medicines - small pieces of plastic being found in medicine December 17, 2014, 3:02 pm (5 year(s) ago) Log in to respond
Jext 300 and 150 micrograms solution for injection in pre-filled pens - problem with delivery of dosage December 17, 2014, 3:02 pm (5 year(s) ago) Log in to respond
Class 4 Drug Alert (Caution in Use): 8.4% w/v Sodium Bicarbonate - B. Braun Melsungen AG - PL 03551/0069 December 17, 2014, 3:02 pm (5 year(s) ago) Log in to respond
Imigran Injection/Subject - syringes may have needles protruding from the needle shield December 17, 2014, 3:02 pm (5 year(s) ago) Log in to respond
NovoMix 30 Penfill 100U/ml, 3ml and NovoMix 30 FlexPen 100U/ml, 3ml – cartridges contain too much or too little insulin in batches December 17, 2014, 3:02 pm (5 year(s) ago) Log in to respond
Multiple products by Wockhardt UK Limited – 2nd site certificate withdrawn December 17, 2014, 3:02 pm (5 year(s) ago) Log in to respond
Natzon 0.4mg Sublingual Tablets - wrong blister packs in cartons December 17, 2014, 3:02 pm (5 year(s) ago) Log in to respond
Warfarin 3mg tablets - higher than expected levels of degradation December 17, 2014, 3:01 pm (5 year(s) ago) Log in to respond
Multiple products by Wockhardt UK Limited – certificate for manufacturing site withdrawn December 17, 2014, 3:01 pm (5 year(s) ago) Log in to respond
Erythromycin Oral Suspension – manufacturers certificate withdrawn December 17, 2014, 3:01 pm (5 year(s) ago) Log in to respond
Hydroxyethyl starch (HES) products - increased risk of renal dysfunction and mortality December 17, 2014, 3:00 pm (5 year(s) ago) Log in to respond
AmBisome 50mg Powder for Solution for Infusion - potential lack of sterility assurance December 17, 2014, 3:00 pm (5 year(s) ago) Log in to respond
Ventolin Syrup sugar-free 2mg in 5ml - risk of glass fragments in the bottles December 17, 2014, 3:00 pm (5 year(s) ago) Log in to respond
Questran 4g sachet Powder for Oral Suspension - possible contamination with Enterococcus faecium December 17, 2014, 3:00 pm (5 year(s) ago) Log in to respond
Ativan Injection 4mg/ml - glass particles identified December 17, 2014, 2:59 pm (5 year(s) ago) Log in to respond
Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - misalignment of syringe label December 17, 2014, 2:59 pm (5 year(s) ago) Log in to respond
Diazepam 2mg Tablets - does not comply with the required specification December 17, 2014, 2:59 pm (5 year(s) ago) Log in to respond
Miacalcic 200 IU Nasal Spray Solution - withdrawn throughout the European Union December 17, 2014, 2:59 pm (5 year(s) ago) Log in to respond
Circadin 2mg prolonged-release tablets – error in patient information leaflet December 17, 2014, 2:59 pm (5 year(s) ago) Log in to respond
Cytarabine Injection 100mg/ml (1g/10ml) - potential for crystallisation December 17, 2014, 2:59 pm (5 year(s) ago) Log in to respond
Montelukast 5 mg Chewable Tablets - error on the carton December 17, 2014, 2:59 pm (5 year(s) ago) Log in to respond
Desloratadine ratiopharm 5mg film-coated tablets - higher than expected levels of impurities detected December 17, 2014, 2:58 pm (5 year(s) ago) Log in to respond
Dexamfetamine Sulphate 5mg Tablets – packs may contain 3 blister strips instead of 2 December 17, 2014, 2:58 pm (5 year(s) ago) Log in to respond
Gygel Contraceptive Jelly – test results did not comply with required specifaction December 17, 2014, 2:58 pm (5 year(s) ago) Log in to respond
Tredaptive modified-release tablets - withdrawn throughout the European Union December 17, 2014, 2:58 pm (5 year(s) ago) Log in to respond
Vimpat 150mg Tablets - blister strips are incorrectly labelled December 17, 2014, 2:58 pm (5 year(s) ago) Log in to respond
Typhim Vi - Typhoid Polysaccharide Vaccine - antigen levels below required specification December 17, 2014, 2:58 pm (5 year(s) ago) Log in to respond
Diflucan powder for oral suspension (10 mg/ml and 40 mg/ml) - amended labels and patient information leaflet December 17, 2014, 2:58 pm (5 year(s) ago) Log in to respond
Epistatus, Midazolam 10mg in 1ml Buccal Liquid x 5ml - packs containing new syringes to be distributed December 17, 2014, 2:57 pm (5 year(s) ago) Log in to respond
Zovirax Suspension 200mg/5ml - incorrect dosing instructions December 17, 2014, 2:57 pm (5 year(s) ago) Log in to respond
Paracetamol Tablets 500mg - incorrect blister foil December 17, 2014, 2:57 pm (5 year(s) ago) Log in to respond
Anapen 500mcg, 300mcg and Junior 150mcg/0.3ml solution for injection in a pre-filled syringe December 17, 2014, 2:57 pm (5 year(s) ago) Log in to respond
Levothyroxine 100mcg tablets - recall of Teva UK and Numark branded product December 17, 2014, 2:57 pm (5 year(s) ago) Log in to respond
Rabipur - potential problem packaging of syringes December 17, 2014, 2:57 pm (5 year(s) ago) Log in to respond
Vigantoletten (1000 IU Colecalciferol) Tablets – reminder that tablets contain soya oil December 17, 2014, 2:56 pm (5 year(s) ago) Log in to respond
Dekristol (20,000 IU Colecalciferol) Capsules - contain arachis (peanut) oil December 17, 2014, 2:56 pm (5 year(s) ago) Log in to respond
Clopixol Conc Injection (500mg/ml) - cracked ampoules December 17, 2014, 2:56 pm (5 year(s) ago) Log in to respond
Xigris 5 mg and 20 mg recall due to risk/benefit concerns December 17, 2014, 2:56 pm (5 year(s) ago) Log in to respond
Nurofen Plus tablets containing rogue blister strips in additional 2 cartons December 17, 2014, 2:56 pm (5 year(s) ago) Log in to respond
Canesten Pessary - 2 batches have wrong patient information leaflet December 17, 2014, 2:56 pm (5 year(s) ago) Log in to respond
Recall of Avandia 4mg, 8mg, Avandamet 1mg/500mg, 2mg/500mg, 2mg/1000mg, 4mg/1000mg December 17, 2014, 2:55 pm (5 year(s) ago) Log in to respond