# FDA recall D-66318-001

> **Amgen, Inc.** · Class II · drug recall initiated 2013-09-17.

## Product

Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA  91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.

## Reason for recall

Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.

## Distribution

Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.

## Key facts

- **Recall number:** D-66318-001
- **Recalling firm:** Amgen, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-17
- **Report date:** 2013-11-13
- **Termination date:** 2014-06-02

- **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-66318-001

## Citation

> AI Analytics. FDA recall D-66318-001. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/D-66318-001. Source: US FDA. Licensed CC0.

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