Drug 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.
D-1040-2018
Product summary
- Event
- Event 80428
- Status
- Terminated
- Classification
- Class II
- Quantity
- 95 kits
- Official record key
drug-enforcement:D-1040-2018
Official wording
Reason: Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Code information: Lot 4223
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility