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Agenzia Italiana del Farmaco
Global recall: Zerbaxa (ceftolozane / tazobactam) 1 g/0.5 g powder for concentrate for solution for infusion - Global recall: Zerbaxa (ceftolozane / tazobactam) 1 g/0.5 g powder for concentrate for solution for infusion
Global recall: Zerbaxa (ceftolozane / tazobactam) 1 g/0.5 g powder for concentrate for solution for infusion
Global recall: Zerbaxa (ceftolozane / tazobactam) 1 g/0.5 g powder for concentrate for solution for infusion.
Summary
- Seven batches of Zerbaxa (ceftolozane/tazobactam) failed sterility tests. Five of these batches tested positive for Ralstonia pickettii according to the analysis performed by MSD. None of these batches have been released to the market.
- All product batches distributed to the market before this incident have met the registered specifications for release, including for sterility.
- However, as a precautionary measure, MSD is recalling all Zerbaxa within expiry. This is a voluntary recall at pharmacy level. Pharmacies are requested to quarantine all products immediately for collection by <date>.
- Health care professionals should immediately stop using Zerbaxa and consider an alternative treatment for their patients.
Published on: 23 December 2020
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