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Patient safety information

Patient safety information

The Medicines and Healthcare products Regulatory Agency (MHRA) have made changes to the way they issue drug safety messaging to healthcare providers.

MHRA Drug Alerts have been renamed, drug safety notices will no longer be referred to as ‘Drug alerts’ and ‘company led Drug alerts’ for any MHRA safety message which does not meet the criteria of a National Patient Safety Alert. These have now been replaced by ‘Medicines recall/notification’, which will have the same layout and format as previous ‘alerts’. All Class 1 Medicines Recalls will meet the National Patient Safety Alert criteria and will be issued as National Patient Safety Alerts (NatPSA).

A table explaining the new Medicines Recall and Notification classifications and the associated defect risk classification can be found on the gov.uk website.

Changes to titles

Previous title New title
Drug Alert: Class 1 National Patient Safety Alert (NatPSA)(equivalent to Class 1 Medicines Recall)
Drug Alert: Class 2-4 Medicines Recall: Class 2-3
Drug Alert: Caution in Use, Class 4 Medicines Notification: Caution in use, Class 4
Company-Led Drug Alert Company-Led Medicines Recall/Notification

This page contains a list of:

  • patient safety notifications (previously referred to as alerts and recalls) which have previously been highlighted as news stories on the PSNC website;
  • advice and guidance relating to patient safety which have previously been highlighted as news stories on the PSNC website; and
  • a link to the MHRA monthly drug safety updates.

Although pharmacy teams should have responded as appropriate to the above within the required time frames, those that have been highlighted as news stories on the PSNC website have been listed on this page as a quick reference for pharmacy teams to check that they are aware of all of the published notices and have taken appropriate action, where required.

As relevant news stories are published on the PSNC website they will be added to the lists below.

Medicines recall/notification & National Patient Safety Alerts (NatPSA)

Date issued Recall/Notification type Medicines recall/notification
13th June 2022 MHRA Class 2 Medicines Recall

Phenobarbital 60mg tablets
1st June 2022 MHRA Class 4 Medicines Defect Information

OxyContin 20 mg prolonged release tablets

17th May 2022 MHRA Class 2 Medicines Recall

Mefenamic Acid 500mg film coated tablets
5th May 2022 MHRA Class 2 Medicines Recall

Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets
27th April 2022 MHRA Class 2 Medicines Recall

Paroxetine 40mg Film Coated Tablets
11th April 2022 MHRA Class 2 Medicines Recall

Olopatadine USV 1mg/ml Eye Drops
28th March 2022 MHRA Class 2 Medicines Recall

Accuretic 10/12.5 mg film-coated tablets
15th March 2022 MHRA Class 4 Medicines Defect Information

Beclometasone dipropionate 50 micrograms/dose Nasal Spray
14th March 2022 MHRA Class 4 Medicines Defect Information

Latuda film-coated tablets
7th March 2022  MHRA Class 2 Medicines Recall

Diazepam RecTubes 2.5mg Rectal Solution
2nd March 2022 MHRA Class 3 Medicines Recall

Isotard 60mg XL Tablets
17th February 2022 MHRA Class 2 Medicines Recall

Efudix 5% Cream
15th February 2022 MHRA Class 2 Medicines Recall

Water for Injections BP – 100ml vial
3rd February 2022 Class 4 Medicines Defect Information

Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets (Atnahs Pharma UK Limited)
1st February 2022 Class 4 Medicines Defect Information

Ibuprofen 400mg tablets
31st January 2022 Class 4 Medicines Defect Information

Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion (Antibiotice SA)
19th January 2022  MHRA Class 2 Medicines Recall

Ikervis 1mg/ml eye drops
8th December 2021 MHRA Class 2 Medicines Recall

Mydrilate 0.5% Eye Drops 5ml
30th November 2021 MHRA Class 2 Medicines Recall

Irbesartan containing products
29th November 2021 MHRA Class 4 Medicines Defect Information

Mometasone Furoate 50 microgram/Dose Nasal Spray
29th November 2021 Class 4 Medicines Defect Information

Diuril Oral Solution (unlicensed medicine) Mawdsley-Brooks & Company Limited
15th November 2021 MHRA Class 4 Medicines Defect Information

Slenyto 1 mg and 5mg prolonged-release tablets
26th October 2021 Class 3 Medicines Recall

 Bimatoprost 0.3mg/ml eye drops
14th October 2021 Class 2 Medicines Recall

Champix (all strengths) film-coated tablets (Pfizer Ltd)
15th September 2021  MHRA Class 2 Medicines Recall

Ikervis 1mg/ml eye drops
10th September 2021 MHRA Class 4 Medicines Defect Information

Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets
25th August 2021 MHRA Class 2 Medicines Recall

Metformin Hydrochloride 500mg/5ml Oral Solution (Rosemont Pharmaceuticals Limited)
18th August 2021 National Patient Safety Alert

Synthetic Opioids
9th August 2021 MHRA Class 2 Medicines Recall

Irbesartan containing products
19th July 2021 MHRA Class 4 Medicines Defect Information

Amoxicillin 500 mg/ 5 ml Powder for oral suspension, (PL 25298/0248)
12th July 2021 MHRA Class 4 Medicines Defect Information

Sevredol 10mg and 20mg tablets (PL 16950/0063, PL 16950/0064)
6th July 2021 MHRA Class 4 Medicines Defect Information

Tetralysal 300mg Hard Capsules (PL 10590/0019)
16th June 2021 National Patient Safety Alert

Co-codamol 30/500 Effervescent Tablets (Zentiva Pharma UK Ltd)
20th May 2021 MHRA Class 3 Medicines Recall

Carbimazole 10mg and 15mg tablets
17th May 2021 MHRA Class 2 Medicines Recall

Bricanyl Injection, 0.5 mg/ml solution for injection or infusion
4th May 2021 MHRA Class 4 Medicines Defect Information

Syonell 250mg & 500mg gastro-resistant tablets
22nd April 2021 MHRA Class 2 Medicines Recall

Trimethoprim 200mg tablets (Ennogen)
15th March 2021 MHRA Class 3 Medicines Recall

Itraconazole 10mg/ml oral solution

3rd March 2021 MHRA Class 3 Medicines Recall

Easyhaler Salbutamol Sulfate 100 & 200micrograms per actuation
17th February 2021 MHRA Class 3 Medicines Recall Clonidine hydrochloride 50micrograms/5ml oral solution
16th February 2021 MHRA Class 2 Medicines Recall MidaBuc – Midazolam (as HCL) 10mg/mL Oromucosal Solution
8th February 2021 MHRA Class 2 Medicines Recall Palexia 20mg/ml Oral Solution
3rd February 2021 MHRA Class 3 Medicines Recall Kolanticon Gel 500ml (Intrapharm)

Alerts and recalls

Date issued Issue
18th January 2021

MHRA Company Led Drug Alert and Recall: Instanyl 100mcg nasal spray solution
18th December 2020

Company led drug alert: Sodium chloride 0.9% Solution for injection (PL 08828/0178)
15th December 2020

Class 4 Medicines Defect Information: Co-careldopa 25mg/100mg tablets (Fairmed Healthcare GmbH)
14th December 2020

Class 4 Medicines Defect Information: Perindopril Erbumine 2mg, 4mg, 8mg Tablets  (Generics UK Limited T/A Mylan)
3rd December 2020

Class 3 Medicines Recall: Simvador 10mg, 20mg and 40mg tablets (Lupin Healthcare (UK) Limited)
26th November 2020

Class 2 Medicines Recall: Largactil 50mg/2ml solution for injection Aventis Pharma Ltd (trading as Sanofi)
26th November 2020

Class 2 Medicines Recall: Betahistine dihydrochloride 8mg and 16mg tablets (Kent Pharmaceuticals Ltd)
25th November 2020

Class 2 Medicines Recall: Abstral 200microgram sublingual tablets (Kyowa Kirin Ltd)
9th November 2020

Class 4 Medicines Defect Information: Kolanticon Gel 200ml (Intrapharm Laboratories Ltd)
29th October 2020

Class 3 medicines recall: AlfaD Capsules (Theramex) – Update – additional batch included
14th October 2020

Class 3 Medicines Recall: Metoprolol 50mg tablets (Accord)
14th October 2020

Class 2 MHRA Medicines Recall: Epilim 500mg Gastro-Resistant Tablets (Sanofi)
29th September 2020

Class 3 medicines recall: AlfaD Capsules (Theramex)
10th September 2020

Class 4 Medicines Defect Information: Zopiclone 3.75mg Tablets, Zopiclone 7.5mg Tablets (Ratiopharm Uk Limited) and Zopiclone 3.75mg Tablets (Generics Uk T/A Mylan)
7th September 2020

Class 3 Medicines Recall: Amlodipine 10mg Tablets (Accord Healthcare Limited)
1st September 2020 

Class 4 FMD Drug Alert For Information: Kingsley Specials Ltd, Multiple Products
1st September 2020 

Class 2 Medicines Recall: Oxylan 40mg prolonged-release tablets (G.L. Pharma)
21st August 2020

Supply Disruption Alert – Lithium carbonate (Priadel® ) 200mg and 400mg modified release tablets
4th August 2020 Class 2 Medicines recall: Clexane 4,000 IU (40mg) /0.4ml Syringes (Pharmaram Ltd)
3rd August 2020 Class 4 Medicines Defect Information: SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system (Crescent Pharma Ltd)
3rd August 2020 Class 3 Medicines Recall: Digoxin Tablets BP 250 micrograms (Accord-Uk Limited)
29th July 2020 Class 2 Medicines Recall: Abstral 200microgram sublingual tablets (Kyowa Kirin)
23rd July 2020 Class 3 Medicines Recall: Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial) Accord Healthcare Limited
22nd July 2020 Class 4 Medicines defect information: Ecalta 100mg powder for concentrate for solution for infusion (Pfizer Limited)
20th July 2020 Class 4 Medicines defect information: Trimogal 100mg and 200mg tablets (Ennogen Pharma Limited)
20th July 2020 Class 4 Medicines Defect Information: Ibuprofen 200mg and 400mg tablets (Aspar Pharmaceuticals) various liveries
15th July 2020 Class 2 Medicines recall: Desmopressin nasal spray – all strengths (Ferring Pharmaceuticals Limited)
15th July 2020 Class 2 Medicines recall: Nitrofurantoin 50 mg Tablets (Dr Reddy’s Laboratories (UK) Limited)
2nd July 2020 Class 2 MHRA Medicines Recall: Mepacrine Hydrochloride 100mg tablets
30th June 2020 Class 4 Medicines Defect Information: Class 4 Medicines Defect Information: Depo-Provera 150mg/ml Injection (Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder))
8th June 2020 Class 2 Medicines Recall: Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles)- Torbay Pharmaceuticals
28th May 2020 Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection (Torbay Pharmaceuticals (for Veriton Pharma Ltd))
18th May 2020 Class 2 Medicines Recall: Emerade 500 micrograms solution for injection in pre-filled syringe
20th April 2020 Class 4 Medicines Defect Information: Glaxosmithkline Consumer Healthcare (UK) – various products
16th April 2020 Class 4 MHRA drug alert – Levofloxacin 500mg tablets (Teva UK Limited)
7th April 2020 Class 2 Medicines Recall Emerade 300micrograms solution for injection in pre-filled syringe (Pharma Česka Republika S.R.O)
30th March 2020 Class 4 Medicines Defect Information: Paracetamol 250mg/5ml Oral Suspension 500ml (Rosemont Pharmaceuticals Ltd)
25th March 2020 Class 4 Medicines Defect Information: Zamadol SR 50 mg prolonged-release hard capsules (Mylan UK Healthcare Ltd)
19th March 2020 Class 4 FMD Drug Alert For Information: HMS Wholesale Limited – Multiple Products
18th March 2020 Class 2 Medicines recall: Esmya 5 mg tablets (Gedeon Richter (UK) Ltd)
4th March 2020 Class 2 Medicines Recall Emerade 150micrograms solution for injection in pre-filled syringe (Pharma Česka Republika S.R.O)
2nd March 2020 Class 2 Medicines Recall: Tetrabenazine 25 mg tablets (AOP Orphan Pharmaceuticals AG)
27th February 2020 Class 4 Medicines Defect Information: Oxylan Prolonged-release tablets (oxycodone hydrochloride) (G.L. Pharma GmbH T/A Healthcare Pharma Ltd)
25th February 2020 Class 4 Drug Alert – Memantine 10mg tablets (Crescent Pharma Ltd)
24th February 2020 Class 4 Drug Alert: Ibuprofen 400mg Tablets (Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd) – update
17th February 2020 Class 4 FMD Medicines Defect Information: Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection (Accord Healthcare Ltd)
13th February 2020 Class 2 Medicines recall: Gliclazide 40 mg Tablets (Accord-UK Limited)
12th February 2020 Class 3 FMD Medicines Recall: Beconase Aqueous Nasal Spray (Glaxo Wellcome UK Ltd T/A GSK)
12th February 2020 Class 4 Drug Alert Atrolak (Quetiapine) XL (Accord) Caution in use
3rd February 2020 Class 2 Medicines recall: Ranitidine 150mg & 300mg Tablets (Medreich Plc)
30th January 2020 Class 2 Medicines recall: Levothyroxine 100micrograms/5ml Oral Solution (Wockhardt UK Ltd)
29th January 2020 Class 4 MHRA Drug Alert – Finasteride 5mg tablets (Dr. Reddy’s Laboratories (UK) Ltd.)
27th January 2020 Class 2 Medicines recall: Picato 150 mcg/g and 500 mcg/g gel (LEO Pharma)
14th January 2020 Class 4 Medicines Defect Information: Zapain 30mg/500mg Tablets (Advanz Pharma)
16th December 2019 Class 2 Medicines recall: Ranitidine 150mg & 300mg Tablets (Medley Pharma Limited)
5th December 2019 Class 2 Medicines recall: Ranitidine 150mg and 300mg Film-Coated Tablets (Accord Healthcare)
28th November 2019 Class 2 Medicines recall: Emerade 150, 300 and 500 microgram solution for injection in prefilled syringe
27th November 2019 Class 2 Medicines Recall – Paracetamol 500mg tablets 1 x 1000 (M & A Pharmachem Ltd)
11th November 2019 Class 2 Medicines Recall – Omeprazole 40mg powder for solution for infusion (Sandoz) 
25th October 2019 Class 2 Medicines recall Ranitidine 150mg/10ml oral solution (Rosemont)
25th October 2019 Class 2 Medicines recall: multiple ranitidine 75mg tablets (Omega Pharma Limited trading as Perrigo and Galpharm International Limited (part of the Perrigo Group))
24th October 2019 MHRA company-led drug alert – Avonex 30 micrograms/0.5ml Solution for Injection (Biogen Idec UK)
23rd October 2019 Class 2 Medicines recall: Sayana Press 104mg/0.65ml (Pfizer Ltd)
22nd October 2019 Company led drug alert – Docetaxel Injection 80mg/8ml (Pfizer UK)
17th October 2019 Class 2 Medicines recall: Ranitidine Effervescent Tablets 150mg and 300mg
16th October 2019 Class 4 MHRA drug alert – Xonvea 10 mg/10 mg gastro-resistant tablets (Alliance Pharmaceuticals Limited)
16th October 2019 Class 4 MHRA drug alert – Rifadin (Rifampicin) 150mg Capsules
8th October 2019 Class 2 MHRA Medicines Recall: Zantac preparations – POM only (GlaxoSmithKline)
3rd October 2019 Class 4 MHRA drug alert – Emerade 150, 300 and 500 microgram pre-filled syringe
23rd September 2019 Class 2 MHRA Medicines Recall: Bisacodyl 10mg Suppositories (Martindale pharmaceuticals Ltd)
12th September 2019 Class 2 MHRA Medicines Recall – Aripiprazole 1mg/ml oral solution (Dr. Reddy’s Laboratories (UK) Ltd)
30th August 2019 MHRA Alert: Hormone replacement therapy (HRT) and increased risk of breast cancer
30th July 2019 Class 2 MHRA Medicines Recall – Aripiprazole 1mg/ml oral solution (Accord UK in Actavis Livery)
25th July 2019 Class 2 MHRA Medicines recall: FMD Alert (Kosei Pharma UK Ltd, MPT Pharma Ltd, Doncaster Pharmaceuticals Group Ltd and Drugsrus Ltd / P.I.E. Pharma Ltd)
24th July 2019 Class 2 MHRA Medicines recall: Bisacodyl 5mg Gastro-Resistant Tablets (Chanelle Medical)
11th July 2019 Class 4 MHRA drug alert – Emerade 150/300/500 micrograms solution for injection in pre-filled syringe
8th July 2019 Class 4 MHRA drug alert – Phenobarbital Sodium 30mg/ml Injection (Martindale Pharma)
27th June 2019 Class 2 MHRA Medicines recall: FMD Alert (B & S Healthcare)
13th June 2019 Class 2 MHRA Medicines recall: Paracetamol 500mg Tablets (M & A Pharmachem Limited)
13th May 2019 Class 2 MHRA Medicines Recall – Co-amoxiclav 125mg/31.25mg/5ml & 250mg/62.5mg/5ml powder for oral suspension (Sandoz Ltd)
8th May 2019 MHRA Company-led recall – Macopharma intravenous infusion bags (Macopharma)
26th April 2019 Class 4 MHRA Drug Alert – Prednisolone 5mg Tablets (Genethics Europe Ltd (Distributed by Genesis Pharmaceuticals Ltd)) Caution in use
24th April 2019 Class 4 MHRA Drug Alert – Ativan 4mg/1ml Solution for injection (Lorazepam) (Pfizer Limited) Caution in use
9th April 2019 Class 4 MHRA Drug Alert – Chloramphenicol 0.5% W/V Antibiotic Eye Drops (Martindale Pharmaceuticals Limited)
4th April 2019 Class 4 MHRA Drug Alert – Zoledronic acid 5mg solution for infusion (Sun Pharmaceutical Industries Europe BV)
21st March 2019 Class 2 MHRA Medicines recall: Losartan Potassium 50mg and 100mg Film-coated Tablets (Accord Healthcare Limited)
28th February 2019 Class 4 MHRA Drug Alert – Paracetamol Infusion (Accord)
19th February 2019 MHRA medical device alert – Accu-Chek Insight insulin pumps – some need to be fitted with key frames
18th February 2019 Class 4 MHRA Drug Alert – Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe (Laboratoire Aguettant)
13th February 2019 Class 2 MHRA Medicines Recall: Irbesartan / Hydrochlorothiazide (Actavis Group PTC EHF)
4th February 2019 Class 4 MHRA Drug Alert – Amoxicillin 500mg capsules (Accord)
29th January 2019 MHRA medical device alert – FreeStyle Libre flash glucose sensor (Abbott) – Use of barrier methods to reduce skin reactions to the sensor adhesive
24th January 2019 Class 2 MHRA Medicines Recall: Irbesartan 150mg and 300mg tablets (Macleods Pharma UK Limited)
3rd January 2019 Class 2 MHRA Medicines Recall: Irbesartan / Hydrochlorothiazide (Actavis Group PTC EHF)
30th November 2018 Class 2 MHRA Medicines Recall: Valsartan containing products (Teva UK Limited and Mylan) 
14th November 2018 MHRA medical device alert and recall – potential breach in sterile barrier packaging of some products manufactured by ConvaTec Limited.
12th November 2018 MHRA Company led recall Mitomycin-C Kyowa (Kyowa)
22nd October 2018 DHSC Supply Disruption Alert – Epanutin (phenytoin) 30mg/5ml oral suspension
24th September 2018 MHRA Company-led recall Imatinib 400mg capsules (3×10) (Cipla EU)
3rd September 2018 Class 4 MHRA drug alert – Olmetec 20mg Film-Coated Tablets (Daiichi Sankyo)
8th August 2018 CAS alert: Esmya (ulipristal acetate) for the symptoms of uterine fibroids – restrictions to use and requirements
3rd August 2018 Class 1 CAS alert: Unsolicited packages to health-related organisations
31st July 2018 MHRA Medical device alert – Recall of affected batches of Durex condoms
30th July 2018 Class 3 MHRA drug alert – Sodium Cromoglicate 2% Eye Drops and Murine Hayfever Relief 2% Eye Drops (FDC International Ltd)
17th July 2018 MHRA company-led drug alert – Melatonin 10mg capsules (IPS Specials)
9th July 2018 Class 2 MHRA drug alert – Fiasp FlexTouch 100 units/ml solution for injection pre-filled pen (Novo Nordisk)
5th July 2018 Class 1 MHRA drug alert – Valsartan 40mg, 80mg and 160mg capsules (Dexcel Pharma Ltd) and 40mg, 80mg, 160mg and 320mg tablets (Actavis Group PTC EHF)
25th June 2018 MHRA company-led drug alert – Denzapine 50mg/ml oral suspension (Britannia Pharmaceuticals Ltd)
20th June 2018 Class 2 MHRA drug alert – Own-brand children’s glycerine and blackcurrant cough syrups manufactured by Bell, Sons & Co.
19th June 2018 Class 4 MHRA drug alert – Bleo-Kyowa, Powder for Solution for Injection, 15,000 IU (Kyowa Kirin)
18th May 2018 MHRA medical device alert – Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips (Roche Diabetes Care)
16th May 2018 MHRA company-led drug alert – Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension (Rosemont Pharmaceuticals Ltd)
2nd May 2018 Class 3 MHRA drug alert – Latanoprost/timolol 50mcg/ml + 5mg/ml eye drops (FDC Pharma)
18th April 2018 Class 4 MHRA drug alert – Inhixa solution for injection in pre-filled syringe (Techdow Europe AB)
12th March 2018 Class 3 MHRA drug alert – Lynparza (olaparib) 50mg capsules (AstraZeneca)
10th February 2018 CAS alert: Esmya (ulipristal acetate) for uterine fibroids
3rd January 2018 Class 2 MHRA drug alert – Mollipaxin 100mg capsules (Winthrop Pharmaceuticals UK Limited trading as Zentiva)
7th December 2o17 Class 4 MHRA drug alert – BUCCOLAM (midazolam) Oromucosal Solution Pre-filled Syringes (Shire)
28th November 2017 MHRA company-led drug alert – Calcichew-D3 500mg/400 IU caplets (Takeda UK Ltd)
27th November 2017 Class 2 MHRA drug alert – Lipitor (Atorvastatin) 80mg film-coated tablets (Pfizer) and atorvastatin 80mg film-coated tablets (Almus livery)
15th November 2017 Class 4 MHRA drug alert – Bleo-Kyowa, powder for solution for injection, 15,000 IU (Kyowa Kirin)
3rd October 2017 MHRA medical device alert – Alere HIV Combo (Alere Ltd)
29th September 2017 Class 2 MHRA drug alert – Xarelto (Rivaroxaban) 20mg film-coated tablets (Strathclyde Pharmaceuticals Ltd)
20th September 2017 MHRA medical device alert – All Accu-Chek Insight insulin pumps (Roche Diabetes Care)
5th September 2017 Class 4 MHRA medical device alert – Error with the barcodes on selected batches of 8 medicinal products (Focus Pharmaceuticals)
24th August 2017 MHRA medical device alert – NovoPen Echo and NovoPen 5 insulin pens (Novo Nordisk)
31st July 2017 Class 3 MHRA drug alert – Dutor 20mg, 30mg, 40mg and 60mg capsules (Torrent Pharma (UK) Ltd)
30th June 2017 MHRA company-led drug alert – Parallel imported One-Alpha 2mcg/ml drops (Star Pharmaceuticals Ltd repackaged by Servipharm Ltd)
18th May 2017 Class 2 MHRA drug alert – Sodium Cromoglicate 2% drops
2nd May 2017 MHRA medical device alert – All Accu-Chek Insight pumps (Roche Diabetes Care) (updated information for battery management)
28th April 2017 Class 1 CAS alert –  Evidence of harm from fentanyl-contaminated heroin
25th April 2017 MHRA medical device alert – BD Plastipak 100ml catheter tip syringe with Luer slip adaptor (Becton Dickinson (BD))
29th March 2017 Class 2 MHRA drug alert – Diclo-SR 75 tablets (diclofenac sodium)(Strides Pharma UK Ltd trading as Co-pharma)
23rd February 2017 Class 2 MHRA drug alert – Viridal Duo 10mcg/ml and 40mcg/ml powder and solvent for solution for injection
16th February 2017 MHRA company-led drug alert – Ergometrine 0.05% injection (hameln Pharmaceutical Ltd)
1st February 2017 Class 3 MHRA drug alert – Alka-Seltzer Original effervescent tablets & Alka-Seltzer XS effervescent tablets (Bayer plc)
5th January 2017 Class 4 MHRA drug alert – Mirena 20mg/24 hours intrauterine delivery system (Bayer plc)
3rd January 2017 Class 4 MHRA drug alert – Arava (leflunomide) 10mg tablets (Sanofi-Aventis Deutschland GmbH)
14th December 2016 Class 4 MHRA drug alert – Amoxicillin 250mg/5ml sugar free suspension and amoxicillin 125mg/5ml sugar free suspension (Medreich plc)
30th November 2016 Class 2 MHRA drug alert – Evacal D3 (calcium carbonate/colecalciferol) 1500mg/400iu chewable tablets (Teva UK Ltd)
8th November 2016 Class 3 MHRA drug alert – Hydrocortisone 100mg/1ml solution for injection (Amdipharm UK Ltd)
19th October 2016 Class 2 MHRA drug alert – Nacrez 75 tablets (Desogestrel)(Teva UK Ltd)
29th September 2016 MHRA company-led drug alert – Adalat LA 30mg tablets (Quadrant Pharmaceuticals Ltd repackaged by Pharmagen Ltd)
6th September 2016 Class 2 MHRA drug alert – GlucaGen Hypokit (glucagon)(Novo Nordisk Ltd)
24th August 2016 Class 4 MHRA drug alert – Actilyse 20mg and 50mg powder and solvent for solution for injection and infusion (alteplase)(Boehringer Ingelheim Ltd)
15th August 2016 MHRA medical device alert – Accu-Chek Insight insulin pump system (Roche Diabetes Care) withNovoRapid PumpCart cartridges
10th August 2016 MHRA company-led drug alert – Furosemide-Claris 20mg/2ml injection (Claris Lifesciences UK Ltd)
10th August 2016 Class 2 MHRA drug alert – Respontin 250mcg/1ml and 500mcg/2ml nebules (Ipratropium brimide)(Glaxo Wellcome UK Ltd)
10th August 2016 MHRA medical device alert – TRUEresult and TRUEtrack test strips (Nipro Diagnostics)
30th June 2016 MHRA medical device alert – TRUEyou test strips (Nipro Diagnostics)
14th June 2016 Class 2 MHRA drug alert – Medikinet 20mg MR capsules (methylphenidate hydrochloride (B&S Healthcare)
7th June 2016 Class 2 MHRA drug alert – Ikervis 1mg/ml drops emulsion (ciclosporin)(Santen UK Ltd)
25th May 2016 Class 2 MHRA drug alert – Epistatus 10mg/ml oromucosal (Special Products Ltd)
12th May 2016 MHRA medical device alert – Accu-Chek Insight insulin pump system (Roche Diabetes Care)
6th May 2016 Class 2 MHRA drug alert – Rifadin 600mg infusion (Aventis Pharma Ltd trading as Sanofi)
28th April 2016 Class 4 MHRA drug alert – Crestor 5mg tablets (Provisacor)

Advice and guidance

Date issued Issue
14th December 2018

MHRA update: Oral lidocaine-containing products for teething in children
22nd October 2018 MHRA drug alert – Valproate Prevention Programme Update
25th September 2018

Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers
25th June 2018

Resource launched to support with valproate medicines and the pregnancy prevention programme
24th April 2018

Valproate licence change: important information for pharmacy teams
6th April 2018

New video highlights the potential fire hazard with paraffin-based skin products
17th January 2018

Parents and carers advised to inspect Buccolam oral syringes before use
18th August 2017 Corticosteroids: rare risk of central serous chorioretinopathy with systemic and local administration
15th August 2017 Adrenaline auto-injectors: updated advice after European review
8th August 2017 CAS alert: Shortage of adult hepatitis B vaccine
10th July 2017 Novopen and Novopen Echo guidance
7th April 2017 MHRA issues valproate safety resources
26th October 2016 MHRA issues insulin delivery systems change advice
16th September 2016 MHRA updates levonorgestrel-containing contraceptive interactions advice
April 2016 MHRA issues guidance on paraffin-based skin emollients on dressings or clothing
18th February 2016 MHRA issues valproate advice

MHRA drug safety update

MHRA monthly DSU newsletter

Manufacturers' resources

Date issued Issue
1st August 2017 Epilim 100mg crushable tablets risk materials (Sanofi)

Other resources

  • The Community Pharmacy Patient Sfety Group has a number of resources which community pharmacy teams may find useful
  • Joint resource which aims to support community pharmacy teams in helping women and girls who have been prescribed valproate medicines – includes a decision pathway and key points for consideration to prompt conversations between the pharmacy team and their patients.
  • Company Chemists’ Association audit tool for community pharmacy teams to use in reviewing their support for girls and women taking valproate medicines.


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