# FDA recall D-808-2013

> **Pharmalucence, Inc.** · Class III · drug recall initiated 2013-05-30.

## Product

Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2,  Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821

## Reason for recall

Presence of Particulate Matter; particulate found in retain samples

## Distribution

Nationwide & Bahamas, Barbados, Bermuda, Japan

## Key facts

- **Recall number:** D-808-2013
- **Recalling firm:** Pharmalucence, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-30
- **Report date:** 2013-07-31
- **Termination date:** 2013-10-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-808-2013

## Citation

> AI Analytics. FDA recall D-808-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-808-2013. Source: US FDA. Licensed CC0.

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