Product: 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.
Reason for recall: Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Recall initiated: 20180606
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated