# FDA recall D-0226-2017

> **Amgen, Inc.** · Class II · drug recall initiated 2016-12-15.

## Product

AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial,  Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01

## Reason for recall

Lack of Assurance of Sterility: Potential cracks in glass vials

## Distribution

United States and Puerto Rico  No foreign distribution.

## Key facts

- **Recall number:** D-0226-2017
- **Recalling firm:** Amgen, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-15
- **Report date:** 2016-12-28
- **Termination date:** 2017-06-02

- **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-0226-2017

## Citation

> AI Analytics. FDA recall D-0226-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0226-2017. Source: US FDA. Licensed CC0.

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