# FDA recall D-0512-2017

> **Endo Pharmaceuticals, Inc.** · Class II · drug recall initiated 2017-02-22.

## Product

Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.

## Reason for recall

Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance.  ok thanks

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0512-2017
- **Recalling firm:** Endo Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-22
- **Report date:** 2017-03-15
- **Termination date:** 2018-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0512-2017

## Citation

> AI Analytics. FDA recall D-0512-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0512-2017. Source: US FDA. Licensed CC0.

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