AIFA orders the withdrawal of a batch of Deflan 6 mg tablets. Drugs withdrawn since June 2015

Fedaisf editorial staff

Press Release 448

L’Agenzia Italiana del Farmaco ha disposto il ritiro dal mercato di un lotto del medicinale a base di cortisone “Deflan 6 mg compresse” (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.

L’azienda, di concerto con l’AIFA, ha effettuato l’immediato ritiro del lotto dal mercato. L’AIFA invita i pazienti in possesso di Deflan 6 mg compresse a verificare il batch number and expiry date (03/2018) e, se corrispondenti a quello ritirato, a sospenderne l’uso e rivolgersi al proprio medico per una nuova prescrizione.

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Medicines Withdrawn and banned from trade since June 2015

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