# FDA recall D-0588-2018

> **Sagent Pharmaceuticals Inc** · Class II · drug recall initiated 2018-03-05.

## 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 for recall

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

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0588-2018
- **Recalling firm:** Sagent Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-03-05
- **Report date:** 2018-03-21
- **Termination date:** 2020-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Schaumburg, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0588-2018

## Citation

> AI Analytics. FDA recall D-0588-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0588-2018. Source: US FDA. Licensed CC0.

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