Sagent Pharmaceuticals ($SGNT) is widening its recall of antibiotics manufactured by one of its India-based contractors after a customer complained that small, dark particulate matter were found in the solution after it was reconstituted.
The latest action falls on the heels of a recall that came earlier this summer of 3,990 vials of oxacillin for injection. The Schaumburg, IL-based drug company, which specializes in sterile injectables, had another antibiotic-related recall earlier this year that involved a lot of an antifungus treatment that it said might be contaminated with an antibiotic.
According to the most recent FDA Enforcement Report, Sagent announced a nationwide recall of one lot of oxacillin for injection manufactured by India-based Astral SteriTech. The foreign matter found in the vials was identified as iron oxide.
The company said in a release that it was unaware of any problems that might have resulted from patients using oxacillin from the recalled lot.
Although Sagent is on the cusp of becoming part of a Japanese company, for the time being it remains responsible for any recalls. Last month, Nichi-Iko said it would spend $736 million to buy Sagent in a deal it expects to close by the end of September.
- here’s the FDA notification