Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Recalled by Pharmalucence, Inc. Due to Presence of Particulate Matter; particulate found in retain...

Date: May 30, 2013
Company: Pharmalucence, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pharmalucence, Inc. directly.

Affected Products

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

Quantity: 17,260 vials

Why Was This Recalled?

Presence of Particulate Matter; particulate found in retain samples

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pharmalucence, Inc.

Pharmalucence, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report