FDA recall D-1062-2020

Product

DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30

Reason for recall

Failed Stability Specifications

Distribution

Product was distributed throughout the United States.

Key facts

Status

Terminated

Initiation date

2020-03-19

Report date

2020-04-01

Termination date

2021-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kirkland, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1062-2020