Home / Recalls / Sagent Pharmaceuticals Inc / D-0587-2018

D-0587-2018 Class II Terminated

Recalled by Sagent Pharmaceuticals Inc — Schaumburg, IL

Recall Details

Product Type
Drugs
Report Date
March 21, 2018
Initiation Date
March 5, 2018
Termination Date
April 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
176,410 vials

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA.

Code Information

Lot #: AJN601, Exp. Jun-2018; AJN701, AJN702, Exp. Dec-2018

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