# FDA recall D-0435-2023

> **Sagent Pharmaceuticals Inc** · Class II · drug recall initiated 2023-02-28.

## Product

Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01

## Reason for recall

Labeling: Not elsewhere classified

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0435-2023
- **Recalling firm:** Sagent Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-02-28
- **Report date:** 2023-03-15

- **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-0435-2023

## Citation

> AI Analytics. FDA recall D-0435-2023. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-0435-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*