MA - Inspectorate - Prod Defect

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

198, Rue D`Argens, Gzira

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

Recalls

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