Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results

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, 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. 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.

Customers are being notified by fax, email, FedEx, and/or certified mail that includes 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.  Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.

Customers or consumers with any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST.  Healthcare workers who have medical questions about Methylprednisolone Sodium Succinate for Injection, USP may contact Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

CUSTOMER SUPPORT:
Customer Call Center
(866) 625-1618

MEDICAL AFFAIRS
(866) 625-1618, Option 3

SOURCE Sagent Pharmaceuticals, Inc.

Related Links

http://www.sagentpharma.com