Additional space in 2D Data Matrix Code - 2 PC
Due to a technical issue on MAH (Accord Healthcare LTD) side the 2D Data Matrix code was printed erroneously on all packs of the following batches:
GTIN: 05055565716649, Solifenacin succinate_tab_10mg_10 X 10T, Batch: Y18467,
GTIN: 05055565724538, Pemetrexed disodium_Pwd conc sol inf_Vial_#_100mg_#_1, Batch: P2001109, P2000387
The batch numbers on the affected packs contain an extra space which may lead to a wrong scan of the unique identifier (UI) and unsuccessful pack verification in the repository. The root cause has been identified as a wrong machine setting associated with printing characters which generated an extra space in the character set. The manufacurer has confirmed a large CAPA action in order to prevent recurrence of the incident in the future.
Since the human readable elements of the unique identifier (UI) (LOT, EXP, SN a PC) are printed correctly on each pack, the MAH recommends manual verification in order to perform a successful transaction.
The incident has no impact on product quality, and the batches comply with FMD safety features. No further action will be taken in this matter by the respective MAH.