EMA warns of stolen vials of Herceptin

Published: 17-Apr-2014

Italian police are investigating the theft


The European Medicines Agency (EMA) has issued an alert that stolen vials of Roche's cancer drug Herceptin (trastuzumab) have been tampered with and 're-introduced under false credentials into the supply chain in some countries'.

The vials are thought to have been stolen in Italy, including from hospitals, the EMA said.

Italian law enforcement authorities are currently investigating the theft and are looking at whether other medicines may also be affected.

The Agency said no affected product has so far been identified at the hospital level and there are no reports that any harm has come to patients.

Signs seen so far that may indicate a vial is not genuine include: batch numbers and expiry dates on most vials that do not match those on the outer package; liquid is present in some vials of Herceptin powder for solution; evidence of tampering with the rubber stoppers, crimping caps or lids; the falsified vials are labelled as Italian Herceptin 150mg.

Although only a small number of vials is thought to be affected, the marketing authorisation holder for Herceptin, as a precautionary measure, is recalling vials suspected of having being falsified.

The EMA said it is monitoring the situation closely and will provide updates as more information comes available.

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