Recalls and rapid alerts

In order to protect public health, market authorisation holders are required to notify the Medicines Authority of any quality defect in respect of their products. Upon verifying the information received the Authority may recommend a batch recall or restriction of supplies from the distribution chain.

The Authority can also receive notification of product defects from other competent authorities, the medical profession, wholesalers, pharmacies and patients.

Suspected or obvious batch defects can be reported by mail, email, fax or telephone:

By Mail:
Medicines Authority
Sir Temi Zammit Building
Malta Life Sciences Park
San Ġwann SĠN 3000

By Phone: 00356 2343 9000
By Fax: 00356 2343 9161
By Email: inspectorate.adm@gov.mt

Medicinal Product Defect Reporting Form 
Online product defect reporting form 

Out of Hours Quality Defect Reporting

Out of Hours Quality Defect Reporting

Urgent quality defect reports that warrant immediate action and arising outside office hours can be reported on the dedicated telephone number: 00356 79917721

Please click here for Caution in Use Drug Alerts

Please click here for Illegal supply chain alerts

For recalls stock of medicinal products for human use due to pharmacovigilance/safety issues refer to the Safety Recall page.

Recalls

All Marketing Authorisation Holders (MAHs), manufacturers, importers and wholesale dealers are reminded that in the event that they are involved in a recall of batch/es of product from the market they are required to issue a recall letter which should be provided to their clients. Such a recall letter needs to be vetted by and agreed with the Inspectorate and Enforcement Directorate within the Medicines Authority prior to the issue of such a letter.2018

 

  • 2021
  • 2020
  • 2019
  • 2018
  • 2017
  • 2016
  • 2015
  • 2014
  • 2013
  • 2012
  • 2011
  • 2010
  • 2009
  • 2008
  • 2007
  • 2006
  • 2004
  •  

    2021

    Class IV Drug Alert: Diazepam 2mg/5ml Oral Solution Sugar Free, 100ml - 24/03/2021

    Class III Drug Alert: Bromazepam Arena 3mg Tablets - 26/01/2021

    Class IV Drug Alert: Micardis 80mg tab - 13/01/2021

    2020

    Class II Recall of Chlorpromazine hydrochloride 25mg/ml x 2ml (Largactil ®) - Sanofi PL04425/0582 - 02/12/2020

    Class II Recall of Irinotecan Hydrochloride 20mg/ml Concentrate for solution for Infusion - 20/07/2020

    2019

    Class I Medical Recall of Avonex 30μg/0.5ml solution for injection - 28/10/2019

    2018 

    Class II Medicines Recall of Voltaren 50mg Tablets, Diovan 80mg Tablets, Diovan 160mg Tablets - 27/12/2018

    Class II Medicines Recall of Valsartan - 28/11/2018

    Class II Medicines Recall of Valsartan 02/08/2018

    2017

    Pentacol 400mg gastroresistant modified-release tablets - 12/07/2017

    Class I Recall of Albiomin 20% Solution for Infusion 200g/l (50ml & 100ml) - 27/04/2017

    Class III recall Zithroplus 500mg film-coated tablets - 24/04/2017

     2016

    Class 1 Recall GlucaGen® HypoKit - 07/09/2016

    Class IV Actilyse 50mg powder and solvent for solution for injection and infusion - 26/08/2016

    Class IV Medicines Defect Information Caution in use of Pariet Tablets Gastro- Resistant 10mg & 20mg - 22/08/2016

    Class II Recall of Augmentin Duo 400/57mg Oral Suspension-35ml PI555/05601A - 25/05/2016

    Class II Recall of Actifed Tablets - 13-05-2016

    Class I Recall of Rifadin 600mg powder and solvent for solution for injection - 06/05/2016

    Class II Recall of Motiliium 1mg/ml suspension - 22/03/2016

    Class II Recall of Palgotal 75mg/650mg film-coated tablets (Tramadol hydrochloride/Paracetamol) - 22/02/2016

    Class II Recall of Pentacol 400mg gatroresistant modified-release tablets - 15/01/2016

    2015

    Mitoxantrone Injection 2mg-ml Concentrate for Solution for Infusion - 31/12/2015
    Class I Medicines Recall - Polygynax vaginal capsule x 12 Caps - 20/11/2015
    
    Class II Recall of Otrivine 0.05% Nasal Spray Solution - 25/08/2015
    Class II Recall of Bactroban Nasal Ointment/ Cream - 25/08/2015
    Class II recall Diclo 50 - 1A Pharma20 - 20/05/2015
    CLASS II Recall of Tramadol 50mg Capsules (Relonchem)- 08/05/2015
    Class II Recall of l-thyroxine- 14/04/2015

    2014

    Class III Recall Rino-Naftazolina 0.2% Nasal Spray - 30/10/14
    Class I Recall Zovirax Eye Ointment - 24/10/14
    Class II Recall Burinex Injection- 13/10/14
    Class II Recall Menigitec Suspension for Injection - 26/09/14 
    Class II Recall Germoloids ointment and suppositories -24/07/2014
    Class II Recall Germoloids HC Spray- 22/7/14
     Class II Recall NiQuitin Lozenges- 19/02/2014
     

    2013

    Class II Recall Tixylix Syrups (Alston Garrard & Co. Ltd)- 17/12/13
    Class II Recall Sodium bicarbonate 8.4% solution for infusion (B. Braun Melsungen AG)- 03-12-13
    Class II Recall of Fluoxetine 20mg Capsules and Naproxen 250mg Tablets (Wockhardt UK Ltd) - 24-10-2013
    Class II Recall of Allopurinol and Amitriptyline tablets- 21/10/13
    Class II Recall of Muciclar Syrup- 08/10/13 
    Class II Recall of Aciclovir 200mg tablets (Wockhardt UK Ltd) - 28/08/2013
    Class II Recall of Propylthiouracil 50mg tablets (Wockhardt UK Ltd) - 22/08/2013
    Class III Recall of Warfarin 3mg tablets (Teva UK Livery) - 20/08/2013
    Class II Recall of Totamol 25mg, 50mg & 100mg tablets (Wockhardt UK Ltd) - 29/07/2013
    Class II Recall of Metformin 500mg tablets (Wockhardt UK Ltd) - 25/07/2013
    Class II Recall of Aciclovir 800mg tablets (Wockhardt UK Ltd) - 22/07/2013
    Class II Recall of Folic acid 5mg tablets (Wockhardt UK Ltd) - 15/07/2013
    Class I Recall of Ambisone Liposomal Amphotericin B 50mg, Powder for Concentrate for Dispersion for infusion - 19/06/2013
    Class II recall of Cilest 250/35 tablets - 29/05/2013
    Class II recall of Atorvastatin TAD 10mg and 20mg tablets - 20/02/2013
    2012
    Class III recall of Atenolol 100mg tablets (Accord) - 21/11/2012 
    Class III recall of Thymoglobuline Powder for solution for infusion 25mg - 10/08/2012   
    Class III recall of Metformin 500mg coated tablets (Zanza Laboratories) - 11/07/2012
    Class II recall of ViaSpan solution - 18/05/2012   
    Class II recall of Fenazil 2% Cream - 04/04/2012
    Class II recall of Droptimol 0.5% eye drops - 02/02/2012
     2011
    Class II Recall of VELCADE (bortezomib) 1.0mg powder for solution for injection - 25/11/2011
    Class II Recall of CARDIOLITE [Kit for use in the preparation of Technetium_99mTc_Sestamibi]  - 29/08/2011
    Recall of Dianeal and Extraneal solutions for peritoneal dialysis - 19/08/2011
    Class II recall of Droptimol 0.5% eye drops solution - 18/08/2011
    Class I recall of Technescan LyoMAA 2mg pdr for solution for injection - 29/04/2011
    Recall of Dianeal, Extraneal and Nutrineal solutions for peritoneal analysis - 29/04/2011
     2010
    Class I recall of Dianeal PD1 solution for peritoneal dialysis - 22/12/2010
    Class III Recall of Worthington Medical Oxygen Cylinders (35L, 40L, 50L) / Cylinders List - 13/10/2010
    Class I recall of Cisplatine Mylan 50mg/50ml solution for infusion - 05/10/2010
    Class II Recall of Fucidin® (Sodium fusidate) Pdr for Soln for Infusion 500mg vials - 15/07/2010
    Class II Recall Fucidin (Sodium fusidate) Pdr for Soln for Infusion 500mg vials - 12/07/2010
    Class II Recall of Citanest 1% (Prilocaine Hydrochloride) 50ml vials - 17/02/2010
    Class III recall of Salofalk 500mg tablets - 5/1/2010
      2009
    Class I Recall of Compound Sodium Lactate Solution (Hartmann's Solution) / Braun Ltd - 25/11/09
    Class I Recall of Thymoglobuline [Anti-thymocyte Globulin (Rabbit)] 25mg - 09/09/09
    Drug Alert Letter for Rhinathiol sugar-free syrup for children and infants - 14/07/2009
     2008
    Class II Recall of Depo-Provera 150mg/ml suspension for injection in prefilled syringes - 28/07/2008
    Class I recall of Heparin-Rotexmedica solution for injection 5,000 iu/ml - 07/03/2008
     2007
    Class III recall of Parcetamol tablets 500mg x 1000 tabs - 01/11/2007
    Class III recall of Platosin(Cisplatin) 1mg/ml injection fluid, 10ml  - 12/09/2007
    Zyprexa 10mg tablets Drug Alert  - 29/05/2007
    Plavix 75mg tablets Drug Alert - 28/05/2007
    Class II recall of Phlebodia(diosmin) 600mg film-coated tablets - 10/04/2007
    Class I recall of Plavix 75mg coated tablets  - 08/02/2007
    Class III recall of Uzix (Amikacin) solution for injection 500mg/2ml  - 25/01/2007
    Class I rapid alert letter for Avetine (Cefuroxime) 750mg vials - 25/01/2007
    Axetine (cefuroxime) 750mg vial - 23/01/2007
     2006
    Isotretinion 20mg Capsules - 29/09/2006
    Class II recall Sertral 50mg tablets - 14/08/2006
    Class I recall of Ultravist-370 - 3/8/2006
    Class II recall of Lipormerz Reatrd (Etofibrate 500mg) capsules Batch no:503041 - 17/01/2006
     2004
    Class II recall of Pulmicort 200 microgram/dose pMDI -  03/11/2004
    Class II recall of Diclogesic 12.5mg Suppositories - 12/08/2004
    Class II recall of Amsidine 75mg ampoules, solution for infusion - 03/06/2004
     Caution in Use 

    Wockhardt amoxicillin sodium powder for solutin for injection (Class IV Caution in use) - 11/07/2014

    Zarzio pre-filled syringe 30 MU/0.5ml solution for injection (Class IV Caution in use) - 03/05/2013

    Acetylcysteine 200mg/ml injection (Class IV Caution in use) - 30/11/2009

    Enebrel 25mg injection (Class IV Caution in use) - 28/10/2005