Patient safety information

Patient safety information

This page contains a list of:

  • patient safety 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 Medicines and Healthcare products Regulatory Agency (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 these and have taken appropriate action when required.

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

Alerts and recalls

Date issued Issue
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

MHRA drug safety update

Manufacturers' resources

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

Other resources

  • 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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