Sagent Pharmaceuticals Inc., announced a nationwide recall of 10 lots of the injectable anti-inflammatory drug methylprednisolone sodium succinate manufactured by Gland Pharma Ltd., and distributed by Sagent Pharmaceuticals because testing has revealed a high amount of specification impurity. This could decrease the effectiveness of the drug in patients. The impurity has not yet been identified and, to date, no reports of adverse events have been reported.
Methylprednisolone sodium succinate for injection is an anti-inflammatory glucocorticoid that is used for several conditions including allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, neoplastic diseases, nervous system, ophthalmic diseases, renal diseases, respiratory diseases, and rheumatic disorders.
The affected lots of methylprednisolone sodium succinate include 40 mg, 125 mg and 1 g doses, and the product is supplied in 5 ml, 10 ml and 30 ml glass tubular vials. The products were distributed to hospitals, wholesalers and distributors nationwide from April 2017 through February 2018. A list of affected lot numbers can be found on the Sagent Pharmaceuticals’ recall notice.
Companies that received affected lots of this drug were notified and instructed to return all products affected by this recall. Any adverse events experienced after using these products should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice