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Medicines Authority

Awtorità dwar il-Mediċini



 

 

Product Defect Reporting

Product Defect Reporting

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 -            The Medicines Authority

                         203, Rue D`Argens, Gzira 1368.

By Email -           

By Phone    –      00356 23439000

By Fax         –      00356 23439162

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

Guidance note regarding Medicinal Product Defect Reporting 

Medicinal Product Defect Reporting Form - 23/10/09

Please click here for Caution in Use Drug Alerts

Recalls

Class 2 Recall of Fucidin® (Sodium fusidate) Pdr for Soln for Infusion 500mg vials - 15/07/2010

Class 2 Recall Fucidin (Sodium fusidate) Pdr for Soln for Infusion 500mg vials - 12/07/2010

Class 2 Recall of Citanest 1% (Prilocaine Hydrochloride) 50ml vials - 17/02/2010

Class III recall of Salofalk 500mg tablets - 5/1/2010

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 - 9/9/09

Drug Alert Letter for Rhinathiol sugar-free syrup for children and infants

Class II Recall Depo-Provera 150mg/ml suspension for injection in prefilled syringes

Class I recall of Heparin-Rotexmedica solution for injection 5,000 iu/ml

Paracetamol tablets 500mg x 1000tabs (Class III recall)

Platosin(Cisplatin) 1mg/ml injection fluid, 10ml (Class III recall)

 Zyprexa 10mg tablets Drug Alert (May 07)

Plavix 75mg tablets Drug Alert (May 07)

Phlebodia(diosmin) 600mg film-coated tablets Recall (Class II recall)

Plavix 75mg coated tablets (Class 1 recall)

Uzix (Amikacin) solution for injection 500mg/2ml (Class III) recall

Class I rapid alert letter for Axetine (Cefuroxime) 750mg vials

Axetine (cefuroxime) 750mg vial

Isotretinion 20mg Capsules

Sertral 50mg tablets (Class 2 recall) - 14/8/2006

Ultravist-370 (Class 1 Recall) - 3/8/2006

Lipomerz Retard (Etofibrate 500mg) capsules Batch No:503041 Class 2 Recall - 17/01/2006

  Pulmicort 200 microgram/dose pMDI (Class II Medicines Recall)   03/11/2004

  Diclogesic 12.5mg Suppositories (Class II Medicines Recall) get file in pdf format   12/08/2004

  Amsidine 75mg ampoules, solution for infusion (Class 2 Medicines Recall)  get file in pdf format  03/06/2004

Caution in Use

Enbrel 25mg Injection (Class 4 Caution in Use) get file in pdf format 28/10/2005

 

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