# FDA recall D-0499-2024

> **Sagent Pharmaceuticals** · Class II · drug recall initiated 2024-04-25.

## Product

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only,  Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

## Reason for recall

Presence of Particulate Matter: Potential for black particulates in the drug product.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0499-2024
- **Recalling firm:** Sagent Pharmaceuticals
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-04-25
- **Report date:** 2024-05-22

- **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-0499-2024

## Citation

> AI Analytics. FDA recall D-0499-2024. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0499-2024. Source: US FDA. Licensed CC0.

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