Drug product
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.
D-0588-2018
Product summary
- Event
- Event 79419
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48,964 vials
- Official record key
drug-enforcement:D-0588-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Code information: Lot #: AJP701, AJP702, Exp. Dec-2018; AJP601, Exp. Jul-2018; AJP703, Exp. Aug-2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
out of specification