cGMPs / QRM Process

Tampered Vials of Roche Injectable Cancer Drug Found in Germany

Sep 16, 2014

WSJ

A German drug distributor has discovered three vials of Roche's cancer and rheumatoid-arthritis drug MabThera with evidence of tampering.

One vial contained a reduced amount of the drug's active ingredient, while the other two vials had compromised caps, missing information leaflets, or batch numbers on their packaging that didn't match the vials.

The compromised MabThera batches were part of a delivery from a Romanian wholesaler to a German distributor. Roche confirmed that it had supplied the batch to Romanian wholesalers but beyond that denied any control or knowledge of what then happened to the drugs.

Read the WSJ article