Kit For The Preparation Of Technetium Tc 99m Medronate Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 45567-0040
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Kit For The Preparation Of Technetium Tc 99m Medronate (NDC 45567-0040). A significant event, classified as Class II, was initiated on Jun 06, 2018 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Jun 06, 2018
Aug 15, 2018
95 kits
Recall Profile & Regulatory Data
Event ID
80428
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pharmalucence, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 11, 2019
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot 4223
Affected Packages Involved in this Recall
45567-0040-1Product
45567-0040-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
