# FDA recall D-1086-2017

> **Amgen, Inc.** · Class II · drug recall initiated 2017-08-04.

## Product

Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01

## Reason for recall

Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.

## Distribution

United States including Puerto Rico

## Key facts

- **Recall number:** D-1086-2017
- **Recalling firm:** Amgen, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-04
- **Report date:** 2017-08-23
- **Termination date:** 2018-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Thousand Oaks, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1086-2017

## Citation

> AI Analytics. FDA recall D-1086-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1086-2017. Source: US FDA. Licensed CC0.

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