FDA 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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-06-06

Report date

2018-08-15

Termination date

2019-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1040-2018