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The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent due to out-of-specification impurity results.
On March 5, 2018, Sagent Pharmaceuticals announced it is recalling 10 lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent. The recall was initiated after the discovery of high out-of-specification impurity results found during routine quality testing of stability samples for two lots.
The recalled lots were distributed to hospitals, wholesalers, and distributors nationwide from April 2017 through February 2018. At the time of the recall announcement, Sagent was not aware of any adverse events resulting from the recalled product. Adverse events may be reported to FDA’s MedWatch program.
Methylprednisolone Sodium Succinate for Injection, USP is an anti-inflammatory glucocorticoid used to treat multiple conditions including dermatologic diseases, endocrine disorders, and hematologic disorders. According to the company, elevated impurity may decrease the effectiveness of the product.