EMA Warns of Falsified Herceptin Vials

Apr 16, 2014

The European Medicines Agency (EMA) has been informed that vials of the cancer medicine Herceptin, thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials. Italian law enforcement authorities are currently investigating the theft and are looking at whether other medicines may also be affected.

Currently, no affected product has been identified at the hospital level and there are no reports of any patients being harmed.

Signs that may indicate a vial is not genuine include the following: batch numbers and expiration dates on vials that do not match those on the outer package; the presence of liquid in some vials of Herceptin powder for solution (Herceptin is a white to yellow powder); tampered rubber stoppers, crimping caps or lids; and vials falsely labeled as Italian Herceptin 150 mg.

The numbers of the Herceptin batches known to be affected are H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09, and H4303B01. The EMA is coordinating the response by the appropriate health authorities in the Member States.

Source: European Medicines Agency