Sagent Pharmaceuticals asserted the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. The products were manufactured by Gland Pharma ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary retraction of Methylprednisolone Sodium Succinate for injection, USP to the user level due to the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots.
The impurity is yet to be ascertained. An elevated impurity has the ability to decrease effectiveness of the product in patients. To date, Sagent is not aware of any adverse patient events resulting from the use of the subject product lots.
Methylprednisolone Sodium Succinate for Injection, USP is an anti-inflammatory glucocorticoid indicated for a number of conditions, including but not limited to: allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, miscellaneous (trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy), neoplastic diseases, nervous system, ophthalmic diseases, renal diseases, respiratory diseases, and rheumatic disorders.
Customers are being intimated by fax, email , FedEx and/or certified mail that includes arrangements for return of all recalled product arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot of product.