Press Release 448

The Italian Medicines Agency has ordered the withdrawal from the market of a batch of the cortisone-based medicine "Deflan 6 mg tablets" (lot 1501 with deadline 03/2018) since it was informed by the company that holds the Marketing Authorization, "Laboratori Guidotti SpA", that the packs of the aforementioned lot expiring 03/2018, while reporting the wording "Deflan 6 mg tablets" instead contain blisters of tablets with a higher dosage, equal to 30 mg.

The actual dosage of these packs (30 mg) is reported in the blisters and results from the reading of the optical sticker carried out in the pharmacy at the time of dispensing of the drug.

The company, in concert with AIFA, immediately withdrew the lot from the market. AIFA invites patients in possession of Deflan 6 mg tablets to verify the batch number and expiry date (03/2018) and, if they correspond to the one withdrawn, to stop using it and contact your doctor for a new prescription.

Every other package of Deflan having a different combination of dosage, batch and expiry date does not present any defects and can be used regularly.

Deflan tablets is a medicine indicated in the treatment of: insufficient primary and secondary activity of the adrenal glands (alone or in combination with mineralocorticoids). Rheumatic diseases; Allergic states; Collagen diseases; Dermatological diseases Respiratory diseases; Eye diseases; Gastrointestinal diseases.

AIFA – 08/07/2015

Medicines Withdrawn and banned from trade since June 2015

• AIFA Note No. 60019 of 12 June 2015
  Withdrawal of the medicine BRONCHOHEXAL
  
  • The text of the Note (pdf 23.70KB)
• AIFA Note No. 67970 of 3 July 2015
  Withdrawal of the medicine BUDESONIDE VIATRIS NOVOLIZER
  
  • The text of the Note (pdf 42.94KB)
• AIFA Note No. 62731 of 19 June 2015
  Withdrawal of the medicine Miconal
  
  • The text of the Note (pdf 45.62KB)
• AIFA Note No. 58552 of 9 June 2015
  Withdrawal of the medicine Exempt 20 softgels 1000 mg 
• The text of the Note (pdf 40,70KB)
  • AIFA Note No. 52532 of 22 May 2015
    Withdrawal of the medicine Diclofenac Hexal
    
    • The text of the Note (pdf 273.08KB)
  • AIFA Note No. 52528 of 22 May 2015
    Withdrawal of the medicine Diclofenac Angenerico
    
    • The text of the Note (pdf 248.05KB)
  • AIFA Note No. 50592 of 19 May 2015
    Withdrawal of the medicine Eprex 1000 IU 1X0.5ml syringes
    
    • The text of the Note (pdf 91.84KB)
  • AIFA Note No. 48181 of 13 May 2015
    Withdrawal of the medicine Deltacortenesol
    
    • The text of the Note (pdf 108.14KB)