FDA-Drug2020-04-01Class II
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
Jubilant Draximage Inc
Hazard
Failed Stability Specifications
Sold states
Product was distributed throughout the United States.
Affected count
473 kits of 30 vials
Manufactured in
16751 Rte Transcanadienne, N/A, Kirkland, N/A, Canada
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1062-2020Don't want to check this manually?
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