Pharmalucence, Inc. recalls Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1)
Recalled August 15, 2018 · FDA recall D-1040-2018 · Pharmalucence
Hazard
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility. · FDA Class II
Units
95 kits
Sold at
Nationwide
Description
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
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.
Manufacturer(s)
Pharmalucence, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →