RecallDepth
Class II Terminated

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.

Company
Sagent Pharmaceuticals Inc
Recall Initiated
March 5, 2018
Posted
March 21, 2018
Recall Number
D-0587-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
176,410 vials
Firm Location
Schaumburg, IL, United States

Reason for Recall

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

Distribution

Nationwide in the USA.

Lot / Code Info

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

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