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.

Recall Number: D-1040-2018

Firm: Pharmalucence, Inc.

Classification: Class II

Status: Terminated

Report Date: 20180815

Initiation Date: 20180606

Termination Date: 20190311

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

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.