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Pfizer Inc recollected their Piperacillin and Tazobactum vials after the detection of elevated levels of impurities which may results in decreased potency. According to the US FDA the product was manufactured in Chennai, India by Hospira Healthcare India Pvt Ltd, which is a Pfizer company having their plant at Irungattukottai near Chennai for Apotex Corp is to be sold in the USA.
The Apotex Corp also notified their wholesalers and distributer to arrange for the return of any recalled product, through a letter. Similar to it, AuroMedics Pharma LLC, which is a subsidiary of Aurobindo Pharmaceutical had also started recollecting the vials of piperacillin and tazobactam, it’s estimated that there will be around 77,400 vials currently to be recollected. Whereas Pfizer Inc has recalled over 1.8 million vials of piperacillin and tazobactam.
As per the FDA, the product has been found to contain particulate matter, which is visible only after the reconstitution that was confirmed to be glass within the vial.
The piperacillin and tazobactam is used for treating different types of bacterial infection caused by bacteria..
The piperacillin and tazobactam is used for treating different types of bacterial infection caused by bacteria. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial, the FDA said.”Piperacillin and tazobactam have been found to contain elevated levels of impurities that may result in decreased potency. The affected product is manufactured by Hospira Inc., a Pfizer Company and distributed in the US market by Apotex Corp,” the notification said.
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As on May 14, AuroMedics Pharma LLC has not received reports of any adverse effect or identifiable safety concerns attributed to the product, it said