# FDA recall D-1148-2014

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2014-01-22.

## Product

Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.

## Reason for recall

Subpotent; 18 month time point

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1148-2014
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-22
- **Report date:** 2014-03-12
- **Termination date:** 2016-05-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Island, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1148-2014

## Citation

> AI Analytics. FDA recall D-1148-2014. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1148-2014. Source: US FDA. Licensed CC0.

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