# FDA recall D-1173-2017

> **Amgen, Inc.** · Class II · drug recall initiated 2017-09-13.

## Product

Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044

## Reason for recall

Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1173-2017
- **Recalling firm:** Amgen, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-13
- **Report date:** 2017-09-27
- **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-1173-2017

## Citation

> AI Analytics. FDA recall D-1173-2017. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-1173-2017. Source: US FDA. Licensed CC0.

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