- Sagent Pharmaceuticals is voluntarily recalling one lot of its injectable antibiotic Oxacillin in the U.S. after iron oxide particulate matter was found in one vial of the drug, according to a recall notice posted on the Food and Drug Administration's website.
- While Sagent said no adverse patient event had occurred due to the metal particulate, its presence in the vial is a significant safety risk.
- Another batch of Oxacillin had been recalled in June after two product complaints which cited the presence of dark particulate matter found in solution after reconstitution. Both batches had been manufactured by Astral SteriTech Private Ltd for distribution by Sagent.
Sagent had distributed the lots in question to hospitals, wholesalers and distributors across the U.S. in November through December 2015 and between June and July of this year, respectively.
The more recent quality control issue comes one month after Japanese drugmaker Nichi-Iko Pharmaceutical agreed to acquire Sagent for about $736 million in an effort to expand into the U.S. injectables market.
Sagent's problems with Oxacillin also underscore the continuing quality control issues with Indian drugmakers. The contract manufacturer used by Sagent, Astral SteriTech, is based in Gujarat, India.
The product recalled by Sagent is Oxacillin for Injection, USP, 10g, Lot OXT512.