# FDA recall D-1327-2015

> **Fresenius Kabi USA, LLC** · Class III · drug recall initiated 2015-07-28.

## Product

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01

## Reason for recall

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1327-2015
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-28
- **Report date:** 2015-08-19
- **Termination date:** 2016-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Zurich, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1327-2015

## Citation

> AI Analytics. FDA recall D-1327-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1327-2015. Source: US FDA. Licensed CC0.

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