Sagent Pharmaceuticals ($SGNT), a U.S. company that sells sterile injectables mostly sourced from contractors, is having to recall a lot of an antifungus treatment that it says is contaminated with an antibiotic.
The Schaumburg, IL-based Sagent is voluntarily recalling one lot of fluconazole injection in 0.9% sodium chloride that is sold in 100-mL and 200-mL flexible containers. It said that in stability tests at 18 months, it was discovered that the product had elevated levels of the antibiotic metronidazole.
The company said it was unaware of any adverse events tied to the contamination but warned that any drug with an elevated impurity could be less effective, while any patients already receiving metronidazole would potentially get too much of that drug.
The product was manufactured for Sagent by ACS Dobfar, an Italy-based company that specializes in manufacturing cephalosporin, carbapenem and penicillin APIs and finished dose products.
Sagent specializes in sterile injectables, most of which are manufactured by a network of dozens of contractors it uses to quickly source its ingredients and get its finished products. It does have a 300,000-square-foot, FDA-approved facility in Chengdu, China, that it built when it realized it needed to have some manufacturing capacity of its own.
The recall comes as reports have surfaced that Sagent has advisory firm Perella Weinberg Partners out shopping the $200 million valuation company. Reports are that interest has already come from a handful of Indian drugmakers.
- here's the recall notice