Pfizer Inchas recalled over 1.80 million vials of piperacillin and tazobactam that were manufactured in India, from the US market as they were found to contain elevated levels of impurities that may result in decreased potency.
According to a notification of the US Food and Drug Administration, the product was manufactured by Hospira Healthcare India Private Limited, a Pfizer company, at its plant at Irungattukottai near Chennai for Apotex Corpto be sold in the USA.
The combination of piperacillin and tazobactam is used to treat different infections caused by bacteria
“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.
Apotex Corp. has notified wholesalers and distributor through a letter to arrange for the return of any recalled product.
Similarly, AuroMedics Pharma LLC, an Aurobindo pharmaceutical subsidiary, has also started voluntary recall of 77,400 vials of piperacillin and tazobactam.
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.
{{/usCountry}}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.
{{/usCountry}}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.