Sagent announced it had transferred production of Atracurium Besylate – an injectable agent used during surgery – to its own facility last night, after recalling two lots of the drug produced on its behalf by Emcure at its facility in Pune, India.
The US firm said the recall was prompted by concerns raised by US Food and Drug Administration (FDA) inspectors about aseptic and good manufacturing practices (GMP) at the site “potentially impacting product sterility.”
The recalled drug was distributed to hospitals, wholesalers and distributors nationwide from February 2014 through February 2015.
The FDA has not published details of the observations Sagent cites, however, according to the FDAzilla website agency staff visited the Pune facility in March last year.
The Emcure site in Pune was involved in a recall initiated by Teva Pharmaceuticals last year that involved nearly 23,000 bottles of methyldopa pills and related to cGMP deviations and laboratory testing practices.
The Indian contract manufacturing organisation (CMO) did not respond to a request for comment.
Supplies set to resume in March
Atracurium Besylate is on the World Health Organisation (WHO) list of essential medicines. The drug is not on the US FDA’s shortage list, although it was previously.
However, supplies are limited according to the American Society of Health Systems Pharmacists (ASHP), which attributes the shortfall to production delays at Hospira and Hikma’s decision not to actively market the drug after taking over Bedford Labs last year.
The ASHP post – published the day of the recall – suggests Sagent will begin shipping the drug sometime next month.