methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.

Recall Number: D-0587-2018

Firm: Sagent Pharmaceuticals Inc

Classification: Class II

Status: Terminated

Report Date: 20180321

Initiation Date: 20180305

Termination Date: 20200415

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.