Research & Development
Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g Due to High Level of Impurity
7 March 2018 - - US-based pharmaceutical company Sagent Pharmaceuticals, Inc. has issued a voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g, the company said.
These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals.
Sagent has initiated this recall 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. This impurity has not yet been identified.
An elevated impurity has the potential 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. The lot numbers being recalled were distributed to hospitals, wholesalers and distributors nationwide from April 2017 through February 2018.
Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. 
This recall is being conducted with the knowledge of the US Food and Drug Administration.
Sagent is a customer-focused company, delivering an extensive portfolio of injectable products and fulfilling patients' needs through its network of global resources.
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