D-0588-2018 Class II Terminated
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
- 48,964 vials
Product Description
methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: AJP701, AJP702, Exp. Dec-2018; AJP601, Exp. Jul-2018; AJP703, Exp. Aug-2019