27.03.2015
To the attention of all wholesale distributors of medicinal products
Please be informed that certain distributors in Germany and a pharmacy in the Czech Republic have been provided for sale batches of NEULASTA 6mg, pre-filled syringe x 0,6ml [batch numbers 1076277B, 1047277B, 1052487C (expiry date 03.2017), 1053673A (expiry date 06.2017)] suspected of being falsified. The medicinal product has been imprinted in German. On grounds of suspicion of falsification, the German distributors and the Czech pharmacy have not purchased the product concerned.
Please notify the NAMMD promptly if you have purchased any of the respective batches or if you have received an irregular offer for purchase of Neulasta (for instance, at an unusually low price or with quality certificates different in aspect from those normally issued by AMGEN).
Batch no. 1047277B must be blocked from sale without delay and withdrawn from patient use level, since this is not an AMGEN original batch number.
As regards batch no. 1046277B, each packaging thereof must be checked. Please inform the NAMMD forthwith in case of tampering signs.
A press release issued by the German competent authority (BfARM) is available here.