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The National Medicines Agency (EOF) announced its decision to withdraw a known antibiotic.
According to the relevant EOF announcement, the recall refers to certain batches of the antibiotic ZERBAXA® PD.C.SO.IN (1 + 0.5) G / VIAL., Which is in the form of injectable powder, for dissolution and infusion intravenous.
The decision to withdraw the drug was made “due to out-of-specification results in infertility tests performed,” as stated in an EOF announcement.
The EOF announcement
“The withdrawal of lots T005517 (expiration on 02/28/2022), T005841 (expiration on 02/28/2022), T016334 (expiration
02/28/2022), T022772 (expiring 06/30/2022) and T025186 (expiring 06/30/2022) of the drug ΄ZERBAXA® PD.C.SO.IN (1 + 0.5) G / VIAL ΄΄, due to out-of-specification results in infertility tests performed under post-production stability control.
This Decision is issued cautiously within the framework of the defense of public health in order to strengthen the voluntary withdrawal of the company MSD AFBEE “
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