Warning for counterfeit drug Remicade

Recall for drug: Counterfeit Remicade in circulation

04/23/2014

For some batches of the drug Remicade® (infliximab) an immediate recall was ordered. These could be counterfeit, posing an acute threat to patients. Several of the batches had been stolen in Italy and some have landed in Germany.

Immediate recall for multiple batches
As reported by the German Pharmacists' Medicines Commission, the Paul Ehrlich Institute (PEI) has ordered the immediate recall of a few batches of Remicade® (infliximab). The potentially counterfeit Remicade batches (100 mg powder for solution for infusion) have reached Germany via the parallel distribution according to PEI. The lot numbers of the means recalled are: 3RMA66304, 3RMA67102, RMA68106 and 3RMA67602. The medicines could pose an acute threat to patients.

Unclear whether stolen goods in Germany has come on the market
In addition, the Italian Authorizing Authority has also been informed that packs of the following Remicade batches have also been stolen in Italy: 3RMKA85003, 2RMA65203, 3RMA63602, 3RMA63301. According to PEI, it is not yet known whether this stolen product has come on the market in Germany. Remicade is used for the treatment of various diseases, such as rheumatoid arthritis, Crohn's disease or psoriasis. There are currently no indications that manipulated Remicade vials have been delivered.

Various drugs have been manipulated
Only a few days ago had been reported: Counterfeit cancer drug Herceptin in circulation. The European Medicines Agency (EMA) had been informed that vials of the cancer medicine Herceptin (active ingredient: trastuzumab) had apparently been stolen, tampered with, and returned to the market with false certificates. Shortly thereafter, the Federal Institute for Drugs and Medical Devices (BfArM) had informed that possibly also ampoules with the drugs Alimta and Humatrope could have been manipulated.

Affected packs must not be used
According to the EMA, the Italian authorities are investigating the case, whose gravity and criminal energy are exceptional. The national authorities of the EU countries are involved in the investigation of affected batches and, at the same time, all packaging of the batches concerned would be recalled throughout the EU. In Germany, the affected importers were instructed by the PEI to directly contact the wholesalers and pharmacies supplied and to individually perform and document the recall from pharmacies and users. Nevertheless, all pharmacies are advised to take precautionary measures to check the stock for the batches mentioned. The packs concerned must be separated and must not be used. (Sb)