Sagent Pharmaceuticals issued a voluntary nationwide recall of 10 lots of methylprednisolone sodium succinate for injection after detecting higher-than-specified impurities during routine quality testing.
The specific impurity has yet to be determined, the company said in a statement, adding that it is not aware of any adverse events to patients who might have used the lots.
The products were manufactured by Gland Pharma Ltd.—which is owned by China's Fosun Pharma—and distributed by Sagent Pharmaceuticals. The impurities were at a level that have the potential to decrease effectiveness of the product in patients.
The lot numbers being recalled were distributed to hospitals, wholesalers and distributors in the U.S. from April 2017 through February 2018.
Methylprednisolone sodium succinate is used as an anti-inflammatory glucocorticoid for the treatment of conditions like allergic reactions, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders and other diseases and disorders.
Illinois-based Sagent issued a voluntary recall in 2016 of antibiotics manufactured by one of its India-based contractors after a customer complained that small, dark particulate matter was found in the solution after it was reconstituted. The foreign matter found in the vials was identified as iron oxide.