← Alert archive

MHRA alerts issued in 2021

118 alerts.

• Field Safety Notices: 29 to 31 December 2021

  31 Dec 2021 · Field safety notice (devices)

• Company led medicines recall: Dermaved Sensitive Cream (unlicensed medicine), CLMR (21)A/09

  30 Dec 2021 · Medicines recall/notification

• Field Safety Notices: 20 to 24 December 2021

  24 Dec 2021 · Field safety notice (devices)

• Class 4 Medicines defect information: Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL), EL(21)A/39

  21 Dec 2021 · Medicines recall/notification · EL (21)A/39

  Class 4
• Rheovalves disposable needle-free valves: stop using specific lots due to risk of breakage in patient. DSI/2021/010

  20 Dec 2021 · Device safety information

• Field Safety Notices: 13 to 17 December 2021

  20 Dec 2021 · Field safety notice (devices)

• 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

  20 Dec 2021 · Medicines recall/notification · EL (21)A/38

  Class 2
• Class 4 Medicines Defect Information: SmofKabiven Central emulsion for Infusion, Fresenius Kabi Ltd, EL (21)A/37

  16 Dec 2021 · Medicines recall/notification · EL (21)A/37

  Class 4
• Field Safety Notices: 6 to 10 December 2021

  13 Dec 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Lucentis 10 mg/ml solution for injection in pre-filled syringe EL (21)A/36

  13 Dec 2021 · Medicines recall/notification · EL (21)A/36

  Class 2
• Class 2 Medicines Recall: Intrapharm Laboratories Ltd, Mydrilate 0.5% Eye Drops 5ml, EL (21)A/35

  8 Dec 2021 · Medicines recall/notification · EL (21)A/35

  Class 2
• Field Safety Notices: 29 November to 3 December 2021

  6 Dec 2021 · Field safety notice (devices)

• Medical device alerts archived in December 2021

  3 Dec 2021 · Device safety information

• Field Safety Notices: 22 to 26 November 2021

  1 Dec 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL(21)A/34

  30 Nov 2021 · Medicines recall/notification · EL (21)A/34

  Class 2
• Class 4 Medicines Defect Information: Mometasone Furoate 50 Microgram / Dose Nasal Spray, Suspension, PilsCo Ltd, EL (21)A/33

  29 Nov 2021 · Medicines recall/notification · EL (21)A/33

  Class 4
• Class 4 Medicines Defect Information: Diuril Oral Solution (unlicensed medicine), Mawdsley-Brooks & Company Limited, EL (21)A/32

  29 Nov 2021 · Medicines recall/notification · EL (21)A/32

  Class 4
• Handpieces used in the phacoemulsification technique of cataract removal: need for careful cleaning (DSI/2021/009)

  24 Nov 2021 · Device safety information

• Field Safety Notices: 15 to 19 November 2021

  24 Nov 2021 · Field safety notice (devices)

• Class 3 Medicines Recall: Martindale Pharma, an Ethypharm Group Company Methadone 5mg Tablets / Physeptone 5mg Tablets, EL (21)A/31

  22 Nov 2021 · Medicines recall/notification · EL (21)A/31

  Class 3
• 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

  18 Nov 2021 · Medicines recall/notification · EL (21)A/30

  Class 2
• Company led medicines recall: Dotarem solution for injection (10ml Vial) - PL 12308/0016

  17 Nov 2021 · Medicines recall/notification

• Field Safety Notices: 8 to 12 November 2021

  15 Nov 2021 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Slenyto 1 mg and 5mg prolonged-release tablets – distributed by Flynn Pharma Ltd, EL (21)A/29

  15 Nov 2021 · Medicines recall/notification · EL (21)A/29

  Class 4
• Class 2 Medicines Recall: Cold & Flu Relief Capsules (GSL) – Various Liveries, Wrafton Laboratories Limited (trading as Perrigo), EL (21)A/28

  11 Nov 2021 · Medicines recall/notification · EL (21)A/28

  Class 2
• Medical device alerts archived in November 2021

  9 Nov 2021 · Device safety information

• Field Safety Notices: 1 to 5 November 2021

  8 Nov 2021 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Vygoris Limited, Mitocin (mitomycin) 20mg powder for solution for injection/infusion or intravesical use, EL (21)A/27

  8 Nov 2021 · Medicines recall/notification · EL (21)A/27

  Class 4
• 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

  2 Nov 2021 · Medicines recall/notification · EL (20)A/36

  Class 4
• Field Safety Notices: 25 to 29 October 2021

  1 Nov 2021 · Field safety notice (devices)

• Class 3 Medicines Recall: Bimatoprost Aspire 0.3mg/ml eye drops, solution in single-dose container, Aspire Pharma Limited, EL (21)A/26

  26 Oct 2021 · Medicines recall/notification · EL (21)A/26

  Class 3
• Field Safety Notices: 18 to 22 October 2021

  25 Oct 2021 · Field safety notice (devices)

• 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%

  21 Oct 2021 · Medicines recall/notification

• Field Safety Notices: 11 to 15 October 2021

  19 Oct 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: Pfizer Ltd, Champix (all strengths) film-coated tablets, EL (21)A/25

  14 Oct 2021 · Medicines recall/notification · EL (21)A/25

  Class 2
• 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

  12 Oct 2021 · Medicines recall/notification · EL (21)A/24

  Class 2
• Field Safety Notices: 04 to 08 October 2021

  11 Oct 2021 · Field safety notice (devices)

• Medical device alerts archived in October 2021

  7 Oct 2021 · Device safety information

• Field Safety Notices: 27 September to 01 October 2021

  4 Oct 2021 · Field safety notice (devices)

• Company led medicines recall: Glucose 10%w/v 10ml injection (unlicensed medicine) and Trometamol 7%w/v injection 5mL (unlicensed medicine)

  4 Oct 2021 · Medicines recall/notification

• Field Safety Notices: 20 to 24 September 2021

  27 Sept 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: Accord-UK Ltd (Trading style: NorthStar), LEVOTHYROXINE TABLETS BP 50 micrograms EL (21)A/23

  27 Sept 2021 · Medicines recall/notification · EL (21)A/23

  Class 2
• Field Safety Notices: 13 to 17 September 2021

  20 Sept 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited), IKERVIS 1 mg/mL eye drops, emulsion, EL (21)A/22

  15 Sept 2021 · Medicines recall/notification · EL (21)A/22

  Class 2
• Field Safety Notices: 6 to 10 September 2021

  13 Sept 2021 · Field safety notice (devices)

• Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets (EL (21)A/21)

  9 Sept 2021 · Medicines recall/notification · EL (21)A/21

  Class 4
• Field Safety Notices: 30 August to 3 September 2021

  6 Sept 2021 · Field safety notice (devices)

• Medical device alerts archived in September 2021

  2 Sept 2021 · Device safety information

• Field Safety Notices: 23 to 27 August 2021

  31 Aug 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: Rosemont Pharmaceuticals Limited, Metformin Hydrochloride 500mg/5ml Oral Solution, PL 00427/0139, EL (21)A/20

  25 Aug 2021 · Medicines recall/notification · EL (21)A/20

  Class 2
• Field Safety Notices: 16 to 20 August 2021

  23 Aug 2021 · Field safety notice (devices)

• Field Safety Notices: 9 to 13 August 2021

  16 Aug 2021 · Field safety notice (devices)

• Field Safety Notices: 2 to 6 August 2021

  9 Aug 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL (21)A/19

  5 Aug 2021 · Medicines recall/notification · EL (21)A/19

  Class 2
• Field Safety Notices: 26th to 30th July 2021

  2 Aug 2021 · Field safety notice (devices)

• Field Safety Notices: 19 to 23 July 2021

  26 Jul 2021 · Field safety notice (devices)

• Field Safety Notices: 11 to 16 July 2021

  19 Jul 2021 · Field safety notice (devices)

• Class 4 Medicines Defect Information, Amoxicillin 500 mg/ 5 ml Powder for oral suspension, (PL 25298/0248), EL (21)A/18

  19 Jul 2021 · Medicines recall/notification · EL (21)A/18

  Class 4
• Field Safety Notices: 5 to 9 July 2021

  12 Jul 2021 · Field safety notice (devices)

• Class 4 Medicines Defect Information, Sevredol 10 mg and 20mg tablets, (PL 16950/0063, PL 16950/0064), EL (21)A/17

  12 Jul 2021 · Medicines recall/notification · EL (21)A/17

  Class 4
• Class 4 Medicines Defect Information, Tetralysal 300mg Hard Capsules, (PL 10590/0019), EL (21)A/16

  6 Jul 2021 · Medicines recall/notification · EL (21)A/16

  Class 4
• Company led medicines recall: Morphine Syringe 50mg/50ml (unlicensed medicine) and Magnesium Sulphate 8mmol/20ml infusion (unlicensed medicine)

  1 Jul 2021 · Medicines recall/notification

• Class 2 Medicines Recall: Kyowa Kirin Limited, Xomolix 2.5 mg/ml solution for injection, EL (21)A/15

  1 Jul 2021 · Medicines recall/notification · EL (21)A/15

  Class 2
• Medical devices sterilised by Steril Milano – potential for incomplete sterilisation (DSI/2021/008)

  29 Jun 2021 · Device safety information

• Field Safety Notices: 21 to 25 June 2021

  28 Jun 2021 · Field safety notice (devices)

• National Patient Safety Alert: Philips ventilator, CPAP and BiPAP devices: Potential for patient harm due to inhalation of particles and volatile organic compounds (NatPSA/2021/005/MHRA)

  23 Jun 2021 · National patient safety alert

• Field Safety Notices: 14 to 18 June 2021

  21 Jun 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: Bristol Laboratories Limited, Brown & Burk UK Ltd, Teva UK Ltd, Irbesartan-containing and Losartan-containing products, EL (21)A/14

  17 Jun 2021 · Medicines recall/notification · EL (21)A/14

  Class 2
• National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Co-codamol 30/500 Effervescent Tablets, Batch 1K10121, Zentiva Pharma UK Ltd, due to precautionary risk of causing overdose, NatPSA/2021/004/MHRA

  16 Jun 2021 · National patient safety alert

  Class 1
• Field Safety Notices: 7 to 11 June 2021

  14 Jun 2021 · Field safety notice (devices)

• Company led medicines recall: Noidecs T20/C4 (THC 20%; CBD <4%) Indica Cannabis Flower (unlicensed medicine) and Noidecs T20/C4 (THC 20%; CBD <4%) Sativa Cannabis Flower (unlicensed medicine)

  9 Jun 2021 · Medicines recall/notification

• Field Safety Notices: 31 May to 4 June 2021

  7 Jun 2021 · Field safety notice (devices)

• Field Safety Notices: 24 to 28 May 2021

  1 Jun 2021 · Field safety notice (devices)

• Field Safety Notices: 17 to 21 May 2021

  24 May 2021 · Field safety notice (devices)

• Class 3 Medicines Recall: Advanz Pharma, Carbimazole 10mg and 15mg tablets, EL (21)A/13

  20 May 2021 · Medicines recall/notification · EL (21)A/13

  Class 3
• Company led medicines recall: LysaKare 25 g / 25 g solution for infusion (PLGB 35145/0005)

  19 May 2021 · Medicines recall/notification

• Field Safety Notices: 10 to 14 May 2021

  17 May 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: AstraZeneca UK Limited, Bricanyl Injection, 0.5 mg/ml solution for injection or infusion (PL 17901/0112), EL (21)A/12

  17 May 2021 · Medicines recall/notification · EL (21)A/12

  Class 2
• Targeted communication: CE mark suspended for all MAGEC systems manufactured by NuVasive Specialized Orthopedics, Inc. (DSI/2021/007)

  10 May 2021 · Device safety information

• Field Safety Notices: 3 to 7 May 2021

  10 May 2021 · Field safety notice (devices)

• Recall of BD Venflon Pro safety and Venflon Pro IV cannula (DSI/2021/006R)

  4 May 2021 · Device safety information

• Field Safety Notices: 26 to 30 April 2021

  4 May 2021 · Field safety notice (devices)

• Class 4 Medicines Defect Information, Syonell 250mg Gastro-Resistant Tablets,(PL 35507/0191), Syonell 500mg Gastro-Resistant Tablets, (PL 35507/0192), EL (21)A/11

  4 May 2021 · Medicines recall/notification · EL (21)A/11

  Class 4
• Field Safety Notices: 19 to 23 April 2021

  26 Apr 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: Ennogen Pharma Limited, Trimethoprim 200mg Tablets (PL 40147/0083), EL (21)A/10

  22 Apr 2021 · Medicines recall/notification · EL (21)A/10

  Class 2
• Total parenteral (TPN) and enteral nutrition bags manufactured by Diffuplast: Sterilisation issue (DSI/2021/005)

  20 Apr 2021 · Device safety information

• Field Safety Notices: 12 to 16 April 2021

  19 Apr 2021 · Field safety notice (devices)

• Field Safety Notices - 05 April to 09 April 2021

  19 Apr 2021 · Field safety notice (devices)

• Field Safety Notices - 29 March to 02 April 2021

  6 Apr 2021 · Field safety notice (devices)

• Dexcom G6 Sensor: untested barrier methods to reduce skin reactions (DSI/2021/004)

  6 Apr 2021 · Device safety information

• Medoject sterile hypodermic and blunt fill needles manufactured by Chirana T. Injecta – discontinue use (DSI/2021/003)

  29 Mar 2021 · Device safety information

• Field Safety Notices - 22 to 26 March 2021

  29 Mar 2021 · Field safety notice (devices)

• Field Safety Notices: 15 to 19 March 2021

  22 Mar 2021 · Field safety notice (devices)

• Class 4 Medicines Defect Information, Caffeine Citrate 10mg/ml Solution for Injection, (PL 01883/0344), EL (21)A/09

  18 Mar 2021 · Medicines recall/notification · EL (21)A/09

  Class 4
• Field Safety Notices: 8 to 12 March 2021

  15 Mar 2021 · Field safety notice (devices)

• Class 3 Medicines Recall: Thame Laboratories, Itraconazole 10mg/ml Oral Solution, EL (21)A/08

  15 Mar 2021 · Medicines recall/notification · EL (21)A/08

  Class 3
• National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) (NatPSA/2021/001/MHRA)

  11 Mar 2021 · National patient safety alert

• Class 4 Medicines Defect Information, Diazepam 2mg/5ml Oral Solution Sugar Free (EL (21)A/07) (PL 0142/0103)

  9 Mar 2021 · Medicines recall/notification · EL (21)A/07

  Class 4
• Field Safety Notices: 1 to 5 March 2021

  8 Mar 2021 · Field safety notice (devices)

• Field Safety Notices: 22 to 26 February 2021

  1 Mar 2021 · Field safety notice (devices)

• Class 3 Medicines Recall: Easyhaler Salbutamol Sulfate 100 micrograms per actuation/200 micrograms per actuation inhalation powder, EL (21)A/06

  1 Mar 2021 · Medicines recall/notification · EL (21)A/06

  Class 3
• Targeted letter: Implantable orthopaedic devices manufactured by Implants International Ltd trading as Xtremity Solutions Ltd. (DSI/2021/002)

  26 Feb 2021 · Device safety information

• Field Safety Notices: 15 to 19 February 2021

  22 Feb 2021 · Field safety notice (devices)

• Class 3 Medicines Recall: SyriMed, Clonidine hydrochloride 50micrograms/5ml Oral Solution, EL (21)A/05

  17 Feb 2021 · Medicines recall/notification · EL (21)A/05

  Class 3
• Class 2 Medicines Recall: Eaststone Limited, MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution, EL (21)A/04

  16 Feb 2021 · Medicines recall/notification · EL (21)A/04

  Class 2
• Field Safety Notices: 8 to 12 February 2021

  15 Feb 2021 · Field safety notice (devices)

• Class 4 Medicines Defect Information, AmBisome Liposomal 50 mg Powder for dispersion for infusion, (PL 16807/0001), EL (21)A/03

  11 Feb 2021 · Medicines recall/notification · EL (21)A/03

  Class 4
• Field Safety Notices: 01 to 05 February 2021

  8 Feb 2021 · Field safety notice (devices)

• Class 2 Medicines Recall: Grünenthal Ltd, Palexia 20 mg/ml Oral Solution (PL 21727/0054)

  8 Feb 2021 · Medicines recall/notification

  Class 2
• Class 3 Medicines Recall: Intrapharm Laboratories Ltd, Kolanticon Gel 500ml, EL (21)A/01

  3 Feb 2021 · Medicines recall/notification · EL (21)A/01

  Class 3
• Field Safety Notices: 25 to 29 January 2021

  1 Feb 2021 · Field safety notice (devices)

• Changes to MHRA Drug alert titles and classification

  1 Feb 2021 · Medicines recall/notification

• Field Safety Notices: 18 to 22 January 2021

  26 Jan 2021 · Field safety notice (devices)

• Company led medicines recall: Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001)

  20 Jan 2021 · Medicines recall/notification

• Field Safety Notices: 11 to 15 January 2021

  18 Jan 2021 · Field safety notice (devices)

• Company led medicines recall: Instanyl 100mcg nasal spray solution (EU/1/09/531/015)

  18 Jan 2021 · Medicines recall/notification

• Field Safety Notices: 04 to 08 January 2021

  11 Jan 2021 · Field safety notice (devices)

• Field Safety Notices: 28 to 31 December 2020

  4 Jan 2021 · Field safety notice (devices)

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