Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Kit for the Preparation of Technetium Tc99m Medronate Recalled by Pharmalucence, Inc. Due to Lack of assurance of sterility: Technetium TC-99M Medronate...

Date: June 6, 2018
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

Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

Quantity: 95 kits

Why Was This Recalled?

Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.

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