Schaumburg, Illinois-based Sagent initiated the recall of 3,990 vials of oxacillin last week in a notice on the US Food and Drug Administration (FDA).
Sagent initiated the recall “due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide.”
Sagent recalled a separate batch of the drug in June, also as a result of “dark particulate matter found in solution after reconstitution”
Both the recalled lots were made by Indian contract manufacturing organisation (CMO) Astral SteriTech Private Limited at its facility in Gujarat, India.
Astral was contracted to make injectable drugs for the US market in 2007. Oxacillin was the first drug made by the Indian CMO for which Sagent won approval, in March 2012.
It was launched in July of that year.
Sagent is due to be acquired by Japanese drug manufacturer Nichi-Iko next month in a deal reported to be worth $736m (€649.7m).
The firm has recalled drugs made by Indian contractors before.
In 2015, it withdrew two lots of Atracurium Besylate – an injectable used during surgery – made by Emcure Pharmaceuticals after the US FDA raised concerns about the firm’s facility in Pune, Maharashtra. A few months later the CMO was banned from making drugs for the US market.
Earlier this year the US regulator repeated its concerns about Emcure.
Sagent did not respond to a request for comment.