FDA recall D-0815-2018

Product

Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

Reason for recall

Failed Stability Specifications

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2018-04-10

Report date

2018-05-23

Termination date

2018-10-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0815-2018