FDA Drug recall D-0588-2018
methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Scha…
- FDA Drug
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Scha… by Sagent Pharmaceuticals, citing failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0588-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-05 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sagent Pharmaceuticals |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Identifiers
| code_info | Lot #: AJP701, AJP702, Exp. Dec-2018; AJP601, Exp. Jul-2018; AJP703, Exp. Aug-2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0588-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.