Jubilant Draximage Inc recalls DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured fo…

Recall date

March 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1062-2020

FDA classification

Class II

Brand / firm

Jubilant Draximage Inc

Sold / distributed

Product was distributed throughout the United States.

Why it was recalled

Failed Stability Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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