US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 6, 2018 (8 years ago)

Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a)…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
Pharmalucence, Inc.
NDC code
45567-0040-1
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1040-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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