Alert: Sagent recalls injected methylprednisolone sodium succinate

Sagent Pharmaceuticals announced a voluntary nationwide recall of 10 lots of methylprednisolone sodium succinate (40mg, 125mg and 1g) due to high impurity levels detected during routine quality testing. The products were manufactured by Gland Pharma Ltd.

Methylprednisolone sodium succinate is an anti-inflammatory glucocorticoid indicated for a number of conditions, including various ophthalmic diseases. The product is supplied in 5 ml, 10 ml, and 30 ml glass tubular vials. The lot numbers being recalled were distributed to hospitals, wholesalers and distributors nationwide from April 2017 through February 2018. A detailed list of products and lots is provided in the table below.

Customers are being notified of the recall by fax, email, FedEx and/or certified mail, with instructions for returning all recalled product. Sagent is urging all customers to examine their inventory and to quarantine, discontinue distribution of and return the recalled lot.

The form needed to document this information, as well as other information regarding this recall, is available at www.Sagentpharma.com. Customers with questions about returning unused product should call 1-866-625-1618 during business hours (M-F, 8am-7pm CST).  

Physicians and patients can report adverse reactions or quality issues to the FDA through the MedWatch Adverse Event Reporting site or by mail or fax (1-800-FDA-0178).