# FDA recall D-0010-2025

> **ACCORD HEALTHCARE, INC.** · Class II · drug recall initiated 2024-10-01.

## Product

Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38

## Reason for recall

Failed Impurities/Degradation Specifications.

## Distribution

Nationwide within the United States and PR

## Key facts

- **Recall number:** D-0010-2025
- **Recalling firm:** ACCORD HEALTHCARE, INC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-10-01
- **Report date:** 2024-10-23
- **Termination date:** 2026-02-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raleigh, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2025

## Citation

> AI Analytics. FDA recall D-0010-2025. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0010-2025. Source: US FDA. Licensed CC0.

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