Drug recall D-1040-2018
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.
Lots and codes
Lot 4223
Recall details
- Recalling firm
- Pharmalucence, Inc., Billerica, MA
- Quantity
- 95 kits
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 6, 2018
- Terminated
- March 11, 2019
Related products
- Kit for the Preparation of Technetium Tc 99m Medronate – drug information
- NDC 45567-0040 Kit for the Preparation of Technetium Tc 99M Medronate · Technetium Tc-99m Medronate 20 mg/10mL · Sun Pharmaceutical Industries, Inc.