# FDA recall D-0582-2024

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2024-07-02.

## Product

Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.

## Reason for recall

CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0582-2024
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-07-02
- **Report date:** 2024-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0582-2024

## Citation

> AI Analytics. FDA recall D-0582-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0582-2024. Source: US FDA. Licensed CC0.

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