# FDA recall D-1840-2019

> **Akorn, Inc.** · Class III · drug recall initiated 2019-08-06.

## Product

Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.

## Reason for recall

Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-1840-2019
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-08-06
- **Report date:** 2019-09-04
- **Termination date:** 2022-07-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1840-2019

## Citation

> AI Analytics. FDA recall D-1840-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1840-2019. Source: US FDA. Licensed CC0.

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