# FDA recall D-0229-2015

> **Cubist Pharmaceuticals, Inc.** · Class I · drug recall initiated 2014-08-08.

## Product

CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only,  Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01

## Reason for recall

Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-0229-2015
- **Recalling firm:** Cubist Pharmaceuticals, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-08-08
- **Report date:** 2014-11-05
- **Termination date:** 2016-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0229-2015

## Citation

> AI Analytics. FDA recall D-0229-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0229-2015. Source: US FDA. Licensed CC0.

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